[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changchun GeneScience Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":567},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,46,74,97,118,147,168,192,212,233,254,273,293,319,337,358,377,398,421,443,463,483,500,527,548],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443",false,"NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","18 Years","50 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[27,28,29,30,31,32],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":21},"2026-06-15",{"date":41,"type":21},"2027-05-05",{"name":43,"class":44},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100643745","phase-1-phase-1-clinical-study-of-gensci155-injection-in-healthy-adults-100643745","NCT07638800","Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Doses Study of GenSci155 Injection Administered Intravenously in Healthy Adult Trial Participants","Inclusion Criteria:\n\n1.Healthy adult male or female trial participants, aged between 18 and 60 years (inclusive) Male body weight ≥ 50 kg and female body weight ≥ 45 kg; body mass index (BMI) between 19 and 28 kg\u002Fm² (inclusive) at screening 3.In good general condition as determined by medical history, physical examination, vital signs, ECG, laboratory tests, infectious diseases screening and urine drug screening with no clinically significant abnormalities as judged by the investigator .\n\n4.Female trial participants must have a negative pregnancy test results at screening and baseline.\n\n5.Male and female trial participants of childbearing potential must agree to use non-pharmacological contraception from screening until 3 months after the last dose. From the time of signing the ICF until 3 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female trial participants must have had no unprotected sexual intercourse within 14 days prior to screening.\n\n6.Trial participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to IGF-1 agents or their ingredients; or a history of allergic diathesis or a history of allergic diseases.\n2. History or current presence of hypoglycemia, or recurrent hypoglycemic episodes.\n3. Severe trauma or major surgical procedure within 12 months prior to screening that, in the investigator's judgment, may affect the safety of the trial participants or the interpretation of the study results, or planning to undergo any surgery during the trial period.\n4. Blood loss or donation exceeding 400 mL within 3 months prior to screening.\n5. Poor peripheral venous access; or physical condition intolerant to sampling.\n6. Presence of significant active systemic or local infection within 4 weeks prior to screening.\n7. Presence of tattoo, sunburn, scar or any other factors at screening that may interfere with the assessment of the injection site at the intended injection area.\n8. History or current presence of any clinically significant, poorly controlled chronic disease, organ dysfunction, or malignancy that, in the investigator's judgment, may affect participant safety or study conduct.\n9. Clinically significant abnormalities in chest x-ray \\[P-A\\] at screening.\n10. A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (AntiTP ), or hepatitis B virus (HBV) infection\n11. Females who are breastfeeding during the screening period. 12.12-Lead ECG at screening showing any of the following: QTcF interval \\> 450 ms; or heart rate \\> 100 beats per minute; or any other clinically significant abnormality as determined by the investigator.\n\n13.Any of the following laboratory abnormalities at screening:\n\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \\> upper limit of normal (ULN);\n* Total bilirubin \\> ULN and considered clinically significant by the investigator.\n* Abnormal international normalized ratio (INR) or activated partial thromboplastin time (aPTT) judged to be clinically significant by the investigator.\n* Estimated glomerular filtration rate (eGFR) \\\u003C lower limit of normal;\n* Hematology results below the lower reference limit for any of the following and considered clinically significant by the investigator: hemoglobin, platelet count, white blood cell count, absolute lymphocyte count, or absolute neutrophil count.\n* Triglyceride or low-density lipoprotein cholesterol (LDL-C) levels above the upper reference limit and considered clinically significant by the investigator.\n\n  14.Use of any IGF-1 agents within 6 months or 5 half-lives (whichever is longer) prior to screening.\n\n  15.Use of any prescription drugs, over-the-counter medications (including but not limited to vitamins, herbal supplements, dietary supplements, and health products), traditional Chinese medicines, or Chinese patent medicines within 14 days or 5 half-lives (whichever is longer) prior to screening or planned use during the study period.\n\n  16.Participation in another clinical trial within 3 months or 5 half-lives (whichever is longer) prior to screening (except for trial participants who received no intervention), or current participation in any other clinical trial.\n\n  17.Average daily cigarette consumption of ≥ 5 cigarettes within 6 months prior to screening; or unable to refrain from smoking for the duration of the study; or a positive urine cotinine test.\n\n  18.Weekly intake of alcohol exceeding the criteria \\[defined as \\>14 units of alcohol on average per week (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of spirits)\\] within 6 months prior to screening, or inability to stop drinking during the study, or a positive alcohol test.\n\n  19.Positive urine drug screen for substances including, but not limited to: morphine, ketamine, methylenedioxymethamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine.\n\n  20.History of drug abuse; or use of so-called \"soft\" drugs within 3 months prior to screening; or use of so-called \"hard\" drugs within 1 year prior to screening.\n\n  21.Any other condition that, in the judgment of the investigator, would make the trial participant unsuitable for participation in this clinical trial.",true,"ALL","60 Years",{"count":57,"type":21},68,[24],"This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult trial participants.",[61],"Healthy Adult Trial Participants",[63,64],"Healthy Volunteers","GenSci155","2026-06-04",{"date":67,"type":37},"2026-06-10",{"date":69,"type":21},"2026-07-28",{"date":71,"type":21},"2027-07-28",{"name":43,"class":44},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":53,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":79,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":73},"100634014","phase-1-to-evaluate-the-impact-of-smoking-on-pk-after-single-dose-oral-administration-of-gs1-144-tablets--100634014","NCT07534176","To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .","A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants","Inclusion Criteria:\n\n1)40 to 65 years of age (inclusive) at the time of signing the informed consent form (ICF).\n\n2)Trial participants are healthy females who meet any of the following criteria during screening:\n\n1. Consecutive spontaneous amenorrhea ≥ 12 months.\n2. Consecutive spontaneous amenorrhea ≥ 6 months but \\\u003C 12 months, with serum follicle-stimulating hormone (FSH) levels \\> 40 IU\u002FL.\n3. ≥ 6 weeks after bilateral oophorectomy.\n4. History of hysterectomy with preservation of one or both ovaries and FSH levels \\> 40 IU\u002FL.\n\n   3)Body weight ≥ 45 kg, and body mass index (BMI) within the range of 18-28 kg\u002Fm2 (inclusive).\n\n   4)Able to communicate well with the investigator, understand and comply with all study requirements, voluntarily agree to participate in the trial, and understand and voluntarily sign the ICF.\n\n   5)Smoker:smoking ≥ 10 cigarettes per day within 6 months prior to screening, and urinary cotinine level ≥ 1,000 ng\u002FmL at screening. Smokers will be required to continue smoking in designated areas according to their habits during the study.\n\n   6)Non-smoker: no smoking within 6 months prior to screening, and urinary cotinine level \\\u003C 200 ng\u002FmL at screening.\n\n   Exclusion Criteria:\n   1. Known history of hypersensitivity to the investigational drug, any of its excipients, or related formulations; or a history of allergic disorders (including but not limited to asthma, urticaria); or being allergy-prone (e.g., known allergy to two or more substances).\n   2. History or current diagnosis of diseases of the circulatory, digestive, urinary, respiratory, endocrine and metabolic, hematological and lymphatic, immune, psychiatric and neurological, or dermatological systems, and deemed unsuitable for participation by the investigator.\n   3. History of severe infection, serious trauma, or major surgery within 6 months prior to screening, or planning to undergo surgery during the trial.\n   4. Blood donation or blood loss ≥ 400 mL, or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood within 1 month after the end of the trial.\n   5. Use of any prescription medications \\[including but not limited to drugs known to alter hepatic enzyme activity (e.g., glucocorticoids, sex hormones, anticonvulsants, cyclosporine)\\] within 4 weeks prior to screening, or use of any over-the-counter (OTC) medications (including but not limited to herbal medicines, herbal compound prescriptions, health supplements) or vitamin supplements within 2 weeks prior to screening.\n   6. Trial participants with abnormal findings in physical examination, chest X-ray, abdominal and urinary ultrasound, genital ultrasound, thyroid and parathyroid ultrasound, or laboratory tests at screening, which are deemed unsuitable for participation by the investigator.\n   7. During screening or on D-1, any of the following liver function test results as follows: alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.2 × ULN.\n   8. Abnormal vital signs and deemed unsuitable for participation by the investigator, or systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg during screening.\n   9. Abnormal 12-lead ECG findings and deemed unsuitable for participation by the investigator, or QTcF \\> 470 ms (Fridericia's formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate) during screening.\n   10. Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TP-Ab) during screening.\n   11. Participation in another clinical trial within 3 months prior to screening (except for trial participants who did not receive any investigational intervention), or current participation in any other clinical trial.\n   12. Current or past history of drug abuse within 1 year, or positive urine multi-drug test panel.\n   13. Positive alcohol breath test or history of excessive alcohol consumption (defined as \\>14 units of alcohol per week) within 3 months prior to screening (One standard alcohol unit is equivalent to 17.5 mL or 14 g of pure ethanol. Alcohol content is labeled by volume (ABV) for all beverage types. This corresponds approximately to 35 mL of 50% spirits or 350 mL of 5% beer), or unwillingness to abstain from alcohol or any alcohol-containing products during the trial.\n   14. Consumption of food or beverages that may affect drug metabolism (e.g., containing grapefruit, starfruit, or their products) within 48 hours prior to admission.\n   15. Excessive consumption of tea, coffee, or caffeinated beverages (\\>8 cups per day, 1 cup=250 mL) within 3 months prior to screening; or consumption of any food or beverage containing or metabolized to caffeine or xanthine (e.g., coffee, tea, chocolate, cola) within 24 hours prior to admission.\n   16. Pregnant or lactating women, or those who have a clinically significant positive pregnancy test result.\n   17. Poor venous access, a history of difficult venipuncture, intolerance to venipuncture\u002Fintravenous indwelling needle, or needle\u002Fblood phobia.\n   18. Other conditions deemed unsuitable by the investigator.","40 Years","65 Years",{"count":84,"type":21},24,[24],[87],"Postmenopause","RECRUITING","2026-05-25",{"date":91,"type":37},"2026-05-27",{"date":93,"type":37},"2026-05-20",{"date":95,"type":21},"2027-02-08",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":73},"100624274","phase-1-gensci145-as-monotherapy-or-in-combination-therapy-in-participants-with-pik3ca-mutated-locally-advanced-or-metastatic-solid-tumors-100624274","NCT07407504","GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.","An International, Multicenter, Open-label, Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of GenSci145, as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.","Inclusion Criteria:\n\n* Ability to understand and voluntarily provide written ICF.\n* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol-specified procedures.\n* Age 18-75 years (inclusive) at the time of providing informed consent.\n* Disease diagnosis requirements:\n\nPart 1:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic solid tumors.\n2. Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.\n\nPart 2:\n\n1. Histologically or cytologically confirmed HR+\u002FHER2- locally advanced or metastatic breast cancer \\[HR+ is defined as estrogen receptor (ER) positive and\u002For progesterone receptor (PR) positive (≥10% of tumor cell nuclei showing positive staining); HER2- is defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with a negative in situ hybridization (ISH) result\\].\n2. Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.\n\nPart 3 (doublet) and Part 4 Cohort 1:\n\n1. Histologically or cytologically confirmed HR+\u002FHER2- locally advanced or metastatic breast cancer.\n2. Patients must meet one of the following:\n\n   1. Disease progression during (neo)adjuvant endocrine therapy or within 12 months after completion of such therapy, without having received any prior therapy for metastatic disease.\n   2. Disease progression occurring more than 12 months after completion of adjuvant endocrine therapy, followed by first-line endocrine therapy for metastatic disease, with subsequent progression on that therapy.\n   3. Newly diagnosed advanced breast cancer with progression after first-line endocrine therapy.\n3. Received ≤1 line of chemotherapy for advanced disease.\n4. Prior use of CDK4\u002F6 inhibitors must meet one of the following:\n\n   1. Received CDK4\u002F6 inhibitor therapy in the advanced setting with disease progression occurring during or within 12 months after treatment.\n   2. Discontinued treatment due to intolerability caused by adverse reactions (e.g., hyperglycemia, rash).\n   3. If not previously treated with a CDK4\u002F6 inhibitor, a reasonable explanation must be provided (e.g., lack of drug availability).\n\nPart 3 (triplet) and Part 4 Cohort 3:\n\n1. Histologically or cytologically confirmed HR+\u002FHER2- locally advanced or metastatic breast cancer.\n2. Disease progression during adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen, or within 12 months after completion of adjuvant endocrine therapy. If a CDK4\u002F6 inhibitor was included as part of the (neo)adjuvant therapy, disease progression must occur \\>12 months after completion of CDK4\u002F6 inhibitor therapy.\n\nPart 4 Cohort 2:\n\n1. Histologically or cytologically confirmed HR+\u002FHER2- locally advanced or metastatic breast cancer with brain metastases; diagnosis and treatment requirements are consistent with those for Part 3 (doublet) and Part 4 Cohort 1.\n2. No immediate need for CNS-specific treatment (e.g., radiotherapy or surgery), as determined by the investigator.\n\nPart 4 Cohort 4:\n\n1)Histologically or cytologically confirmed advanced solid tumors other than breast cancer, including but not limited to head and neck squamous cell carcinoma, gynecologic malignancies, or colorectal cancer.\n\n2)Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.\n\n* Female participants enrolled in the breast cancer cohorts must meet one of the following conditions:\n\n  1. Postmenopausal status, defined as any of the following:\n\n     1. Surgical bilateral oophorectomy performed ≥14 days prior, with recovery to baseline status.\n     2. Age ≥60 years.\n     3. Age \\\u003C60 years, amenorrhea ≥12 months, and follicle-stimulating hormone (FSH) and estradiol (E2) levels within the postmenopausal range according to local reference values, without the use of oral contraceptives, hormone replacement therapy, or gonadotropin-releasing hormone agonists\u002Fantagonists.\n  2. Premenopausal or perimenopausal (perimenopause defined as age ≥50 to \\\u003C60 years, with amenorrhea \\\u003C12 months or FSH and\u002For E2 not within the postmenopausal range): must initiate ovarian function suppression with a luteinizing hormone-releasing hormone agonist (e.g., goserelin or leuprolide) ≥2 weeks prior to Day 1 of Cycle 1 and continue throughout the study.\n* A tumor tissue test report confirming the presence of a PIK3CA mutation must be available.\n* Provision of fresh tumor tissue (preferred) or archived tumor tissue collected within 2 years.\n* At least one measurable lesion as assessed by RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy ≥3 months.\n* Adequate hematologic and organ function within 7 days prior to the first dose of GenSci145,as Hematology,Hepatic Function,Renal Function,Glucose Metabolism,Coagulation.\n* Women of childbearing potential (WOCBP) must voluntarily agree to use adequate contraception from the time of signing the ICF until at least 60 days after the last dose of GenSci145 (or up to 2 years if in combination with fulvestrant, in accordance with local prescribing information), and must have a negative serum human chorionic gonadotropin (hCG) test within 7 days prior to the first dose of GenSci145.\n* Male participants with reproductive potential must voluntarily agree to use adequate contraception from the time of signing the ICF until at least 98 days after the last dose of GenSci145 (or up to 2 years if in combination with fulvestrant, in accordance with local prescribing information).\n\nExclusion Criteria:\n\n* History of any active malignancy within ≤2 years prior to the first dose of GenSci145, except for the malignancy under investigation in this study and any curatively treated locally recurrent malignancies\n* Presence of symptomatic, untreated, or progressing CNS metastases. Participants with previously treated CNS metastases (e.g., by surgery or radiotherapy) are eligible only if all of the following conditions are met:\n\n  1. Disease stable for at least 3 months, with no evidence of progression on imaging within 4 weeks prior to first dose of study treatment, all neurologic symptoms recovered to baseline, and no evidence of new or enlarging brain metastases.\n  2. At least 4 weeks have elapsed since completion of CNS-directed radiotherapy, surgery, or corticosteroid therapy prior to the first dose of study treatment.\n* History of leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.\n* History of acute pancreatitis (within 1 year) or chronic pancreatitis, or radiologic evidence of pancreatic metastases.\n* History of stroke, transient ischemic attack, or other clinically significant cerebrovascular events within 6 months prior to the first dose of GenSci145.\n* Active infection requiring intravenous antibiotics, or other uncontrolled intercurrent illness requiring hospitalization. Minor infections such as periodontal infection or urinary tract infection manageable with short-course oral antibiotics are permitted.\n* Confirmed diagnosis of uncontrolled diabetes mellitus, defined as HbA1c ≥8% and\u002For fasting plasma glucose ≥140 mg\u002FdL (7.7 mmol\u002FL).\n* Uncontrolled hypertension, defined as blood pressure ≥150\u002F90 mmHg despite optimal medical management.\n* Clinically significant cardiovascular disease, including but not limited to:\n\n  1. Myocardial infarction or unstable angina within 6 months prior to the first dose of GenSci145.\n  2. New York Heart Association (NYHA) Class III or higher within 4 weeks prior to the first dose.\n  3. Left ventricular ejection fraction (LVEF) \\\u003C50%, assessed by echocardiogram within 4 weeks prior to the first dose.\n  4. Based on three consecutive resting ECGs collected during the screening, the average QT interval corrected by Fridericia's formula (QTcF) is \\>450 ms for males and \\>470 ms for females.\n\n     Any condition associated with increased risk of torsades de pointes (e.g., persistent hypokalemia despite standard treatment, family\n  5. history of long QT syndrome).\n  6. Any clinically significant cardiac rhythm, conduction, or resting ECG abnormality (e.g., complete left bundle branch block, second- or third-degree atrioventricular block).\n* Interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring corticosteroid treatment, or other severe pulmonary diseases affecting lung function.\n* Gastrointestinal disorders that, in the opinion of the investigator, may interfere with the absorption of oral GenSci145, such as peptic ulcer disease, uncontrolled nausea or vomiting, malabsorption syndrome, history of small bowel resection, or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).\n* Uncontrolled serosal effusion, including pleural effusion, ascites, or pericardial effusion (participants with effusions that are controlled and stable for ≥2 weeks after treatment may be eligible).\n* Prior treatment with PI3K, mTOR, or AKT inhibitors.\n* Prior treatment with fulvestrant (except in Phase 1a and Part 4 Cohort 4).\n* Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of GenSci145.\n* Prior anticancer therapies before the first dose of GenSci145 as follows:\n\n  1. Herbal medicines or traditional Chinese medicines with antitumor activity within 2 weeks\n  2. Endocrine therapy with antitumor indications within 2 weeks or 5 half-lives (whichever is shorter).\n  3. Radiotherapy within 4 weeks.\n  4. Chemotherapy within 4 weeks (≥6 weeks for nitrosoureas or mitomycin; oral fluoropyrimidines allowed within 14 days or 5 half-lives, whichever is longer).\n  5. Small molecule targeted agents, biologics, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter).\n* Major surgery within 4 weeks prior to the first dose of GenSci145, or currently recovering from surgery, or planned major surgery during the study.\n* Use of strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), or drugs known to prolong the QT\u002FQTc interval, within 5 half-lives or 14 days before the first administration of GenSci145.\n\nCurrent or recent systemic corticosteroid therapy, or not fully recovered from adverse reactions of prior systemic corticosteroid use (local administration permitted, e.g., topical for rash, inhalation for COPD, 19.ophthalmic use, or intra-articular injection).\n\n* History of organ transplantation or allogeneic stem cell transplantation.\n* Inability to swallow oral medications (e.g., tablets or capsules) without chewing, breaking, crushing, opening, or otherwise altering the product form.\n\n  22.Positive test results for hepatitis B virus (HBsAg positive; participants must also undergo HBV DNA testing, and levels above the assay ULN will result in exclusion), hepatitis C virus (HCV Ab positive; participants must also undergo HCV RNA testing, and levels above the assay ULN will result in exclusion), or human immunodeficiency virus (HIV Ab positive).\n* Persistent toxicities from prior anticancer therapy of CTCAE v6.0 Grade ≥2 (except for alopecia and ≤Grade 2 peripheral sensory neuropathy, or other ≤Grade 2 adverse events deemed not to pose a safety risk by the investigator).\n* Known severe hypersensitivity to GenSci145 and\u002For any of its excipients; for participants in combination cohorts, known hypersensitivity to fulvestrant or to palbociclib (applicable to Part 3 triplet and Part 4 Cohort 3).\n* Pregnant or breastfeeding women, or women planning to breastfeed during the study or within 60 days after the last dose of GenSci145 (or up to 2 years if in combination with fulvestrant, in accordance with local prescribing information).\n* Participation in another clinical study within 4 weeks prior to the first dose (except for observational, non-interventional studies or participants in the follow-up phase of an interventional trial).\n\nAny other condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.","75 Years",{"count":106,"type":21},186,[24],"An international, multicenter, open-label, Phase 1\u002F2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.",[110],"Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated","2026-05-23",{"date":91,"type":37},{"date":114,"type":37},"2026-04-01",{"date":116,"type":21},"2029-02-21",{"name":43,"class":44},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":73},"100625507","phase-2-phase-iib-clinical-study-to-assess-the-efficacy-and-safety-of-gensci120-injection-in-patients-with-moderately-to-severely-active-ra-who-have-an-inadequate-response-to-at-least-one-dmard-100625507","NCT07423533","Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD","Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Disease-modifying Antirheumatic Drug","Inclusion Criteria:\n\n1. Participants who voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and are willing to strictly follow the clinical study protocol to complete this study;\n2. Male or female participants aged 18- 70 years (inclusive) when signing the informed consent form;\n3. Participants diagnosed with RA according to the 2010 RA classification criteria of the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR), with ACR functional classification Class I-III at screening;\n4. Moderately to severely active RA is defined as TJC ≥ 6 and SJC ≥ 6 at screening and baseline based on 68\u002F66 joint counts, and ESR or C-reactive protein (CRP)\u002FhsCRP exceeding the upper limit of normal at screening. Joints with major surgery history will not be included in TJC and SJC;\n\nExclusion Criteria:\n\n1. Known allergy to any component in the GenSci120 formulation, or a history of allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.\n2. Any autoinflammatory disease or autoimmune disease (excluding secondary Sjogren's syndrome) other than RA, including but not limited to psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, systemic sclerosis or idiopathic inflammatory myopathy, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immunodeficiency syndrome, etc;\n3. Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;\n4. History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;\n5. Those with malignant disease or with a history of malignant disease;","70 Years",{"count":127,"type":21},450,[129],"PHASE2","This is a multicenter, randomized, double-blind, parallel, placebo- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the efficacy and safety of GenSci120 injection in this patient population. The study consists of a screening period (≤ 4 weeks), a placebo-controlled treatment period (14 weeks), an extension treatment period (14 weeks), and a follow-up period (10 weeks), with a total of 17 scheduled visits.",[132],"Rheumatoid Arthritis",[134,135,136,137,138],"rheumatoid arthritis","GenSci120","inadequate response to at least one DMARD","Programmed death receptor-1 (PD-1)","Regulatory T cells","2026-05-21",{"date":141,"type":37},"2026-05-22",{"date":143,"type":37},"2026-04-30",{"date":145,"type":21},"2028-12",{"name":43,"class":44},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":73},"100629585","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-of-gensci161-in-healthy-adult-participants-100629585","NCT07476586","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants","A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarker Characteristics of a Single Subcutaneous Injection of GenSci161 Injection in Healthy Adult Participants","Inclusion Criteria:\n\n1. Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).\n2. Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg\u002Fm² (inclusive).\n3. In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference ranges or deemed clinically insignificant by the investigator.\n4. Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female participants must have had no unprotected sexual intercourse within 14 days prior to the first dose.\n5. Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.\n2. Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic procedures) during the trial period.\n3. Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic \\[helminth\\] infections) at any time from 4 weeks prior to screening until the day of randomization.\n4. Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.\n5. History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not limited to, disorders of the following systems: neuropsychiatric, cardiovascular, urological, gastrointestinal, respiratory, musculoskeletal, metabolic, endocrine, hematologic, immunologic, and dermatologic, as well as any other major medical conditions and malignancies (with the exception of adequately treated or resected, and resolved non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin).\n6. A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (TPPA), or hepatitis B virus (HBV) infection (defined as a positive hepatitis B surface antigen \\[HBsAg\\] and\u002For a positive hepatitis B core antibody \\[HBcAb\\] result).\n7. Administration of any live or live-attenuated vaccine within 12 weeks prior to screening or planning to receive any live or live-attenuated vaccine (with the exception of inactivated influenza vaccine) during the trial period.\n8. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for participation in this clinical trial.","45 Years",{"count":156,"type":21},44,[24],"To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.",[63],"2026-04-27",{"date":162,"type":37},"2026-05-01",{"date":164,"type":37},"2026-04-20",{"date":166,"type":21},"2027-08-10",{"name":43,"class":44},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":16,"minAge":175,"maxAge":81,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":73},"100635518","safety-and-efficacy-of-corifollitropin-alfa-n02-injection-in-elderly-women-undergoing-assisted-reproductive-technology-art-100635518","NCT07553728","Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)","A Multi-center, Single-arm, Observational Study to Assess the Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)","Inclusion Criteria:\n\n1. Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding.\n2. Married women aged 36 to 40 years (exclusive of boundary values).\n3. Normal ovarian function: AMH ≥ 1.1 μg\u002FL and basal FSH \\\u003C 10 IU\u002FL.\n4. Scheduled to undergo controlled ovarian stimulation (COS) and IVF\u002FICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection.\n\nExclusion Criteria:\n\n1. ≥3 previous cycles of controlled ovarian stimulation (COS)\n2. Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion).\n3. Repeated implantation failure: ≥3 embryo transfer cycles (fresh or frozen) or failure to achieve clinical pregnancy after transfer of ≥4 high-quality embryos in total.\n4. High risk of ovarian hyperstimulation syndrome (OHSS), defined by any of the following:\n\n   * Diagnosed with polycystic ovary syndrome (PCOS);\n\n     * Total number of AFC in both ovaries \\>20 on Day 2-3 of menstruation; ③ Previous cycle cancellation (including canceled embryo transfer) due to high ovarian response or high OHSS risk; ④ History of OHSS; ⑤ Other conditions judged by the investigator to confer high OHSS risk after comprehensive evaluation.\n5. Poor ovarian function, defined by any of the following:\n\n   ① Previous poor ovarian response (≤3 oocytes retrieved following conventional full-dose gonadotropin stimulation);\n\n   ② Total AFC in both ovaries \\\u003C5.\n6. Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator.\n7. Abnormal uterine bleeding.\n8. Presence of systemic diseases (e.g., cardiovascular, digestive, neurological, hematological disorders) deemed unsuitable for study participation by the investigator, or severe diseases incompatible with pregnancy.\n9. Hypersensitivity or history of allergy to active ingredients or excipients of gonadotropins (Gn), GnRH antagonists, or progesterone preparations, or with documented contraindications to these medications.\n10. History of alcoholism, heavy smoking, drug addiction, or substance abuse.\n11. Scheduled to undergo preimplantation genetic testing (PGT).\n12. Currently participating in another clinical trials and receiving investigational products.\n13. Any other conditions deemed by the investigator to render the subject unsuitable for trial participation based on safety considerations.","36 Years",{"count":177,"type":21},200,"OBSERVATIONAL","This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.",[181],"Infertility",[183,184],"assisted reproductive technology (ART)","controlled ovarian stimulation (COS)","2026-04-23",{"date":187,"type":37},"2026-04-28",{"date":162,"type":21},{"date":190,"type":21},"2029-12-16",{"name":43,"class":44},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":73},"100635077","phase-2-a-study-of-efficacy-and-safety-of-gensci048-in-subjects-with-active-uveitis-100635077","NCT07547995","A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.","A Phase II Clinical Study to Assess the Efficacy and Safety of GenSci048 in Subjects With Active Non-infectious Uveitis.","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;\n3. Must have active disease at the baseline visit;\n4. Must have demonstrated a prior adequate response to oral corticosteroid therapy (equivalent of oral prednisone up to 1 mg\u002Fkg\u002Fday), as judged by the investigator;\n5. No intention to become pregnant and willingness to use highly effective contraception during the study and for 24 weeks after the last dose of study drug;\n6. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.\n\nExclusion Criteria:\n\n1. Subjects with isolated anterior uveitis;\n2. Subjects with neovascular\u002Fwet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy;\n3. Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baselinevisits;\n4. Any of the following:\n\n   Confirmed active tuberculosis (TB) infection, including but not limited to radiologically confirmed active TB; Subjects with latent TB infection or at high risk for TB may be enrolled, provided they are not considered unsuitable by the investigator (e.g., unwillingness to continue anti-TB treatment per local guidelines after entering the study);\n5. Presence of significant comorbidities, including but not limited to: uncontrolled hypertension (≥200\u002F105 mmHg), congestive heart failure (Stage D), or uncontrolled type 1 or type 2 diabetes (fasting blood glucose \\>7.0 mmol\u002FL or random blood glucose \\>11.1 mmol\u002FL); eligibility will be determined at the discretion of the investigator;\n6. Subject has previous exposure toanti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded);",{"count":200,"type":21},111,[129],"This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.",[204],"Uveitis","2026-04-21",{"date":185,"type":37},{"date":208,"type":21},"2026-06-18",{"date":210,"type":21},"2028-01-13",{"name":43,"class":44},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":125,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":73},"100594235","phase-1-a-clinical-study-of-gensci134-in-healthy-adults-and-adult-growth-hormone-deficiencyaghd-100594235","NCT07016802","A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)","A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency","Inclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);\n* Body Mass Index (BMI): 19.0-24.0 kg\u002Fm² (inclusive of boundary values);\n* Good health status;\n* Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Be able to understand and be willing to sign the written ICF (before any study procedure is performed).\n* Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other specified study procedures.\n* Aged from 20 to 70 years old (inclusive), at the time of signing the ICF.\n* Body mass index (BMI): 18.0-32.0 kg\u002Fm² ((inclusive of boundary values).\n* Meeting any of the following diagnostic criteria for growth hormone deficiency:\n* Adult-onset: Participants with GHD due to hypothalamo-pituitary disorder or relevant treatments (surgery, radiotherapy) or other reasons (infection, traumatic craniocerebral injury, etc.); the participant has no relapse or residual disease is stable for more than 1 year after surgery for pituitary adenoma, surgery for craniopharyngioma or other pituitary gland operation.\n* Childhood-onset: Participants with childhood idiopathic, acquired, congenital GHD or childhood GHD for other reasons.\n* Confirmed diagnosis of AGHD (meeting at least one of the following criteria):\n* Insulin tolerance test: peak GH cut-off point ≤ 5 μg\u002FL.\n* Glucagon challenge test:\n* a) Participants with BMI \\\u003C 25 kg\u002Fm² or high clinical suspicion \\[≥ 3 pituitary hormone deficiencies (PHDs)\\] with BMI 25-30 kg\u002Fm², peak GH ≤ 3 μg\u002FL.\n* b) Participants with BMI \\> 30 kg\u002Fm² or low clinical suspicion (≤ 2 PHDs) with BMI 25-30 kg\u002Fm², peak GH ≤ 1 μg\u002FL.\n* ≥ 3 PHDs and IGF-1 SDS \\\u003C -2.0 at screening.\n* Participants who have not previously received human growth hormone (hGH) therapy or are in the washout period of previous hGH therapy.\n\nExclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Subjects with significant medical history or clinical manifestations determined by the investigator;\n* History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;\n* History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;\n* Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;\n* Subjects with immunodeficiency or immunosuppressive diseases at screening;\n* Subjects who have undergone major surgery within 12 months prior to screening;\n* Subjects with a history of neoplastic diseases;\n* Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Known or suspected hypersensitivity to the investigational medical product and\u002For any of its excipients.\n* Female participants who are pregnant, breast-feeding or intend to become pregnant or are of childbearing potential but not using an effective contraceptive method.\n* Male participants with fertility potential or their partners who do not use an effective contraceptive method.\n* Clinically significant hepatic disease.\n* Clinically significant chronic renal insufficiency.\n* Cardiac failure.\n* Use of any investigational product within 30 days prior to screening or participated in another trial within 30 days prior to dosing.\n* Use of systemic corticosteroids at non-alternative doses within 90 days prior to dosing.\n* Any disorder or treatment which, in the opinion of the investigator, possibly jeopardizes participant's safety or affects his\u002Fher compliance with the protocol.\n* History of diabetes mellitus.\n* History of malignancy or ongoing malignancy.\n* Active Cushing's syndrome within 24 months prior to dosing.\n* Acute severe diseases resulting in weight loss within 180 days prior to dosing.\n* Use of weight-reducing drugs known to affect body weight significantly within 12 months prior to dosing.\n* Presence of a mental or language disorder that impairs the ability to understand or cooperate with the study, unwillingness to participate, or any other condition that, in the opinion of the investigator or treating physician, renders the participant unsuitable for the trial.\n* Anticipated change in lifestyle during the trial.",{"count":220,"type":21},64,[24],"To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.",[29,30,224],"Adult Growth Hormone Deficiency","2026-04-12",{"date":227,"type":37},"2026-04-14",{"date":229,"type":37},"2025-06-09",{"date":231,"type":21},"2026-11-25",{"name":43,"class":44},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":154,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":73},"100621149","phase-1-a-study-of-safety-tolerability-pk-and-pd-of-subcutaneous-gensci136-in-healthy-adults-100621149","NCT07366866","A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.","A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China.","Inclusion Criteria:\n\n1. Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).\n2. Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg\u002Fm2 (both inclusive) at screening.\n3. Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening\u002Fbaseline period and are not breastfeeding.\n4. Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.\n2. Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.\n3. A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and\u002For other major disease that, in the opinion of the investigator, would affect the evaluation of the study.\n4. Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.\n5. Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening \\[including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine\\].\n6. Participants judged by the investigator to be ineligible for other reasons.",{"count":241,"type":21},48,[24],"This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.",[245],"Autoimmune Disease","2026-03-22",{"date":248,"type":37},"2026-03-25",{"date":250,"type":37},"2026-03-16",{"date":252,"type":21},"2027-03-09",{"name":43,"class":44},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":73},"100630716","phase-1-gs1-144-in-participants-with-hepatic-impairment-and-healthy-female-100630716","NCT07491289","GS1-144 in Participants With Hepatic Impairment and Healthy Female","Pharmacokinetic Study of GS1-144 Tablets in Female Participants With Hepatic Impairment and Healthy Female Participants","Inclusion Criteria:\n\n* Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。\n* Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).\n* Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.\n* Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg\u002Fm2 (inclusive).\n* For participants with normal hepatic function, findings from physical examination, vital signs, clinical laboratory tests (hematology, blood chemistry, urinalysis, coagulation tests, thyroid function test \\[FT3, FT4, and TSH\\], and parathyroid hormone), Chest x-ray (PA), abdominal ultrasound examinations, etc., are normal or abnormal without clinical significance.\n* For participants with hepatic impairment, the following inclusion criteria must also be met to be eligible for this study:\n\n  1. Hepatic impairment caused by hepatitis B, hepatitis C, autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc., with Child-Pugh classification assessed as Class A\u002Fmild (Child-Pugh score: 5-6) or Class B\u002Fmoderate (Child-Pugh score: 7-9)\n  2. A stable medication regimen for the treatment of hepatic impairment, complications, and\u002For other concomitant diseases for at least 14 days prior to screening, with no need for modification (e.g., medication type, dose, or dosing frequency); or not receiving medication.\n  3. Clinical laboratory tests: absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (1,000\u002Fmm3), platelets (PLT) ≥ 35.0 × 109\u002FL (35,000\u002Fmm3), hemoglobin (HGB) ≥ 8.0 g\u002FdL (80 g\u002FL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN), creatinine clearance (CLcr, calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n  4. Systolic blood pressure 90-159 mmHg (Inclusive), diastolic blood pressure 60-99 mmHg (inclusive), and pulse rate 50-100 beats per minute (bpm, inclusive).\n\nExclusion Criteria:\n\n* Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.\n* Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.\n* Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.\n* Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.\n* Use of CYP1A2 inducers or CYP1A2 inhibitors within 1 month or within 5 half-lives prior to screening (whichever is longer), and throughout the study (except stable concomitant medications for participants with hepatic impairment).\n* Use of any of the following drugs within 1 month or within 5 half-lives prior to screening (whichever is longer) (including vitamins, hormonal contraceptives, hormone replacement therapy \\[HRT\\], and traditional Chinese medicines, herbal medicines, and Chinese patent medicines \\[e.g., St. John's wort\\]), except for occasional use of acetaminophen (≤ 2 g\u002Fday), topical dermatologic medications (including corticosteroids), and stable concomitant medications for participants with hepatic impairment.\n* Clinically significant abnormal 12-lead ECG findings \\[e.g., tachycardia\u002Fbradycardia requiring drug treatment, second- to third-degree atrioventricular block, or QTcF \\> 470 ms (corrected by Fridericia's formula), or other clinically significant abnormalities\\], and deemed by the investigator as unsuitable for participation.\n* Participation in any clinical study within 3 months or within 5 half-lives prior to screening (whichever is longer) (except those who did not receive treatment).\n* Severe infection, trauma, gastrointestinal surgery, portosystemic shunt, or other major surgeries within 4 weeks prior to screening.\n* Pregnancy, lactation, or a positive serum pregnancy test.\n* Consumption of excessive amounts of tea, coffee, or caffeinated beverages (≥8 cups per day; 1 cup = 250 mL) within 3 months prior to screening; or intake of any food or beverage containing caffeine or xanthine, or that may produce caffeine or xanthine metabolites after ingestion (e.g., coffee, tea, chocolate, cola) within 1 day prior to dosing.\n* Positive urine drug screening (including morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine \\[MDMA\\], tetrahydrocannabinolic acid, or cocaine). Positive alcohol breath test.\n* Any other condition deemed by the investigator to make the participant unsuitable for participation in this study.\n* Participants with normal hepatic function with a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardio-cerebrovascular systems.\n* Participants with normal hepatic function who test positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or TP Ab.\n* participants with hepatic impairment with History of liver transplantation.\n* participants with hepatic impairmen with liver failure or drug-induced liver injury, or with hepatic encephalopathy, hepatocellular carcinoma (except BCLC stage 0), esophageal and gastric variceal rupture bleeding, or other cirrhosis-related complications deemed by the investigator as unsuitable.\n* participants with hepatic impairmen in addition to the primary liver disease, a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, cardiovascular, or cerebrovascular systems, or clinically significant laboratory or other test abnormalities that, in the opinion of the investigator, would make them unsuitable for participation.\n* participants with hepatic impairmen with positive HIV antigen\u002Fantibody screening; if TP Ab is positive, an additional RPR test is required; if the RPR is also positive, the participant must be excluded.",{"count":84,"type":21},[24],"GS1-144 in Participants with Hepatic Impairment and Healthy Female",[265],"Hepatic Impairment and Healthy Female","2026-03-18",{"date":268,"type":37},"2026-03-24",{"date":164,"type":21},{"date":271,"type":21},"2027-06-30",{"name":43,"class":44},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":154,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":73},"100629353","phase-1-a-studyphase-iof-gs3-007a-dry-suspension-in-healthy-chinese-adults-100629353","NCT07473570","A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults","A Phase I Clinical Study of GS3-007a Dry Suspensions in Healthy Chinese Adults: Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalation, and Food Effect Study","Inclusion Criteria:\n\n1. Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;\n2. Body Mass Index (BMI): 19-26 kg\u002Fm² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;\n3. Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures;\n4. From screening day to 3 months after the last dose, have no plans for conception or sperm\u002Fegg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.).\n\nExclusion Criteria:\n\n1. A highly allergic constitution\n2. Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.\n3. Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT\u002FQTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.\n4. Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.\n5. Individuals who are alcoholics or who regularly consumed alcohol within 6 months before the first dose of the trial, or those unwilling to stop drinking or consuming any alcohol-containing products during the entire trial.\n6. Individuals with a history of heavy smoking or those who smoked an average of ≥5 cigarettes per day within the 3 months before screening\n7. Individuals with immune deficiencies or immunosuppressive diseases, malignant tumors, chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive system diseases.\n8. Individuals who underwent major surgery within 6 months before screening or during the screening period, or those who experienced acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months before screening;\n9. Subjects who have donated blood (including blood components) within 3 months prior to the first dose, or have experienced blood loss ≥ 400 mL within 3 months prior to the first dose\n10. Subjects who have participated in any clinical trial and used investigational drugs, vaccines, or devices within 3 months prior to screening\n11. Subjects who have started a significantly abnormal diet within 4 weeks prior to screening or during the screening period, or have special dietary requirements, cannot comply with the standardized diet, or cannot tolerate the high-fat, high-calorie meal in postprandial trials\n12. Female subjects who are pregnant or breastfeeding",{"count":281,"type":21},32,[24],"This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.",[285],"Healthy Adults","2026-03-12",{"date":250,"type":37},{"date":289,"type":37},"2026-01-07",{"date":291,"type":21},"2026-08",{"name":43,"class":44},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":54,"minAge":300,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":73},"100627543","phase-1-a-study-of-gensci134-in-children-with-growth-hormone-deficiency-pghd-100627543","NCT07450001","A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)","A Phase Ib\u002FII Multicenter, Randomized, Open-label, Active-controlled, Single\u002FMultiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Growth Hormone Deficiency","Inclusion Criteria:\n\n1. Informed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.\n2. At the time of signing the Informed consent form (ICF), the following conditions must be met:\n\n   Phase Ib:\n\n   Girls: age ≥3and ≤11 years, breast development at Tanner stage 1, body weight ≥16 kg; Boys: age ≥3 and ≤12 years, testis volume \\\u003C4 mL, body weight ≥16 kg.\n\n   Phase II:\n\n   Girls: age ≥3 and ≤9 years, breast development at Tanner stage 1; Boys: age ≥3 and ≤10 years, testis volume \\\u003C4 mL.\n3. BMI within the range of ±2 SD of the mean BMI for age and sex at screening\n4. Height is at least 2 SD below the mean HT for age and sex (HT SDS ≤ -2.0) at screening according to the normal pediatric population standards\n5. Diagnosis of GHD confirmed by two different GH stimulation tests performed at screening or within 12 months prior to screening.\n6. No prior exposure to GH or IGF-1therapy.\n7. Absence of intracranial tumor, as confirmed by MRI or CT. Images or scans obtained within 1 year prior to screening can be used as screening data if accompanied by a medical evaluation and conclusion.\n8. AHV \\\u003C5 cm\u002Fyear at screening (Phase II only);\n9. BA \\\u003C CA at screening (Phase II only);\n10. IGF-1 SDS ≤ -1.0 at screening (Phase II only).\n\nExclusion Criteria:\n\n1. Presence of one or more pituitary hormone deficiencies in addition to growth hormone deficiency.\n2. Any suspected or known disease likely to affect growth, or any clinically significant abnormality that would preclude the accurate assessment of standing height (Phase II only), including but not limited to:\n\n   * Turner syndrome\n   * Noonan syndrome\n   * Laron Syndrome\n   * Other genetic syndromes with short stature that are caused by chromosomal abnormalities or gene mutations, including but not limited to Prader-Willi syndrome, abnormal SHOX-1 gene analysis, or GH receptor deficiency.\n   * Born small for gestational age\n   * Growth retardation due to malnutrition\n   * Growth retardation due to hypothyroidism.\n   * Short stature with any other clearly identified etiology.\n   * Congenital abnormalities causing skeletal abnormalities, or claudication (Phase II only).\n   * Significant spinal abnormalities (Phase II only).\n3. Epiphyseal closure (Phase II only).\n4. Abnormal liver function, renal function, or coagulation profile\n5. Current or prior history of any malignant disease; or a family history of malignancy.\n6. Presence of impaired glucose metabolism, or HbA1c ≥ 5.7%, or a confirmed diagnosis of diabetes mellitus.\n7. Clear medical history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, hematological, neurological, or metabolic disorders, or any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.\n8. Any clinically significant abnormality in vital signs, physical examinations, laboratory tests, 12-lead ECG, full spine anteroposterior and lateral X-ray, or B-mode ultrasound, other than those associated with the study disease, as judged by the investigator and will make the participant unsuitable for the study.\n9. A positive result for any of the following serological tests during the screening period: HBsAg, Anti-HCV, Anti-HIV, or TP-Ab.\n10. Known highly allergic diathesis or hypersensitivity to growth hormone products or any excipient of the investigational drug.\n11. Participation in another clinical trial within 3 months prior to screening, or if the time since the last dose is less than 5 half-lives of the previous investigational drug at screening.\n12. Receipt of any blood products within 3 months prior to the first dose, poor peripheral venous access, or any medical condition that will preclude tolerance of the blood sampling procedures.\n13. Administration of any vaccine within 14 days prior to the first dose or planned vaccination at any time during the study period.\n14. The participant and\u002For the parent\u002Flegal representative is likely to be non-compliant with respect to study conduct, as judged by the investigator.\n15. Children have been treated with systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening (Phase II only).\n16. Children have been treated with inhaled glucocorticoid therapy at a dose greater than 400 µg\u002Fday of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening (Phase II only).\n17. Receipt within 3 months prior to screening or planned use during the study of medications that may interfere with growth or development (Phase II only).\n18. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.","3 Years","12 Years",{"count":303,"type":21},128,[24,129],"This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation to assess safety, tolerability, PK\u002FPD profile, and immunogenicity of GenSci134 in children with GHD.\n\nPhase II is a multicenter, randomized, open-label, active-controlled, multiple-dose, parallel-group study to assess the efficacy and safety of multiple subcutaneous doses of GenSci134 at different levels versus Norditropin® in children with GHD. It will also evaluate PK\u002FPD profile and immunogenicity to support dose selection for Phase III.",[307],"Pediatric Growth Hormone Deficiency",[309,310],"GenSci134","PGHD","2026-02-27",{"date":313,"type":37},"2026-03-04",{"date":315,"type":21},"2026-03-06",{"date":317,"type":21},"2028-12-31",{"name":43,"class":44},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":54,"minAge":300,"maxAge":301,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":335,"leadSponsor":336,"locationsCount":73},"100627547","phase-1-a-study-phase-1b2-of-gensci134-in-children-with-idiopathic-short-stature-iss-100627547","NCT07450053","A Study (Phase 1b\u002F2) of GenSci134 in Children With Idiopathic Short Stature (ISS)","A Phase Ib\u002FII Multicenter, Randomized, Open-label, Active-controlled, Single\u002FMultiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Idiopathic Short Stature","Inclusion Criteria:\n\n* sInformed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.\n* At the time of signing the Informed consent form (ICF), the following conditions must be met:\n* Phase Ib:\n\nGirls: age ≥3 and ≤11 years, breast development at Tanner stage 1, body weight ≥16 kg; Boys: age ≥3 and ≤12 years, testis volume \\\u003C4 mL, body weight ≥16 kg.\n\n● Phase II: Girls: age ≥3 and ≤9 years, breast development at Tanner stage 1; Boys: age ≥3 and ≤10 years, testis volume \\\u003C4 mL.\n\n* Diagnosis of ISS at the time of ICF signing .\n* BMI within the range of ±2 SD of the mean BMI for age and sex at screening（Phase II only）.\n* No prior exposure to GH or IGF-1 therapy.\n* Historical measurements of body height within 6-18 months prior to screening are available(Phase II only).\n* BA-CA ≤ 1 year at screening(Phase II only).\n\nExclusion Criteria:\n\n* Presence of any suspected or confirmed condition known to affect growth, including but not limited to:\n\n  1. GHD.\n  2. Turner Syndrome.\n  3. Noonan syndrome.\n  4. Laron Syndrome.\n  5. Other genetic syndromes with short stature that are caused by chromosomal abnormalities or gene mutations, including but not limited to Prader-Willi syndrome, abnormal SHOX-1 gene analysis, or GH receptor deficiency.\n  6. Born small for gestational age:\n  7. Growth retardation due to malnutrition.\n  8. Growth retardation due to hypothyroidism.\n  9. Short stature with any other clearly identified etiology.\n* Epiphyseal closure (Phase II only).\n* Abnormal liver function, renal function, or coagulation profile.\n* Current or prior history of any malignant disease; or a family history of malignancy.\n* Presence of impaired glucose metabolism, or HbA1c ≥ 5.7%, or a confirmed diagnosis of diabetes mellitus.\n* Clear medical history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, hematological, neurological, or metabolic disorders, or any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.\n* Any clinically significant abnormality in vital signs, physical examinations, laboratory tests, 12-lead ECG, full spine anteroposterior and lateral X-ray, or B-mode ultrasound, other than those associated with the study disease, as judged by the investigator and will make the participant unsuitable for the study.\n* A positive result for any of the following serological tests during the screening period: HBsAg, Anti-HCV, Anti-HIV, or TP-Ab.\n* Known highly allergic diathesis or hypersensitivity to growth hormone products or any excipient of the investigational drug.\n* Use within a specified period prior to screening or planned use during the study of medications that may interfere with growth hormone secretion or action, or other drugs known to affect growth and development.\n* Participation in another clinical trial within 3 months prior to screening, or if the time since the last dose is less than 5 half-lives of the previous investigational drug at screening.\n* Children have been treated with systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening (Phase II only).\n* Children have been treated with inhaled budesonide or equivalent doses of inhaled glucocorticoids for more than 4 consecutive weeks within the last 12 months prior to screening (Phase II only).\n* Receipt of any blood products within 3 months prior to the first dose, poor peripheral venous access, or any medical condition that will preclude tolerance of the blood sampling procedures.\n* Administration of any vaccine within 14 days prior to the first dose or planned vaccination at any time during the study period.\n* The participant and\u002For the parent\u002Flegal representative is likely to be non-compliant with respect to study conduct, as judged by the investigator.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.",{"count":303,"type":21},[24,129],"This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK\u002FPD profile, and immunogenicity of a single subcutaneous dose of GenSci134 in children with idiopathic short stature (ISS).\n\nPhase II is a multicenter, randomized, open-label, active-controlled, multiple-dose, parallel-group study to assess the efficacy and safety of multiple subcutaneous doses of GenSci134 at different levels versus Norditropin® in children with ISS. It will also evaluate PK\u002FPD profile, immunogenicity, and biomarkers to support dose selection for Phase III.",[330],"Idiopathic Short Stature",[332,309],"ISS",{"date":313,"type":37},{"date":315,"type":21},{"date":317,"type":21},{"name":43,"class":44},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":73},"100614981","phase-1-a-study-of-genssci098-in-subjects-with-graves-disease-100614981","NCT07286656","A Study of GensSci098 in Subjects With Graves' Disease","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Voluntary signed informed consent.\n* Confirmed diagnosis of diffuse toxic goiter (Graves' disease).\n* Abnormal thyroid function tests (e.g., elevated T4, and suppressed TSH).\n* No prior or recent use of antithyroid medications (discontinued for at least 4 weeks).\n* Female participants must be postmenopausal, surgically sterile, or using a highly effective method of contraception.\n* Male participants must agree to practice abstinence, use a highly effective method of contraception， or have undergone vasectomy.\n* Ability to comply with the follow-up schedule and understand and adhere to the study requirements.\n\nExclusion Criteria:\n\n* Non-diffuse toxic goiter-induced hyperthyroidism.\n* Previous radioactive iodine treatment or thyroid surgery.\n* History or risk of thyroid storm.\n* Use of thyroid hormone medications within the past 6 weeks.\n* accompanied by active thyroid eye disease.\n* Thyroid eye disease treated with radiation\u002Fsurgery,or need for urgent surgery surgical or medical intervention.\n* Optic nerve lesions or corneal damage.\n* Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 months\n* Inability to quit smoking during the study.\n* Allergy to the study drug or monoclonal antibodies.\n* Participation in another clinical trial within the past 3 months.\n* Abnormal electrocardiogram.\n* Significant hepatic or renal dysfunction.\n* Pregnancy,breastfeeding,or positive pregnancy test.\n* Positive for HIV,syphilis,hepatitis B,or hepatitis C.\n* History of drug or substance abuse.\n* Other autoimmune diseases requiring treatment.\n* History of malignant tumors.\n* Splenectomy or major surgery within the past 6 months.\n* Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases.\n* Other conditions deemed unsuitable by investigators.",{"count":84,"type":21},[24],"To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease",[29,30,348,349],"GenSci098","Graves Disease","2026-02-13",{"date":352,"type":37},"2026-02-17",{"date":354,"type":37},"2025-11-21",{"date":356,"type":21},"2027-03-18",{"name":43,"class":44},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":54,"minAge":300,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":73},"100612970","phase-2-a-phase-ii-study-of-peg-rhgh-injection-for-short-children-born-small-for-gestational-age-efficacy-safety-and-pharmacokinetics-100612970","NCT07260500","A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics","A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Polyethylene Glycol Recombinant Human Growth Hormone Injection in Short Children Born Small for Gestational Age (SGA)","Inclusion Criteria:\n\n* Born full-term and \"small-for-dates\" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .\n* At least 3 years old on the day the parent signs the consent form.\n* Still prepubertal (Tanner stage I - no signs of puberty yet).\n* Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.\n* Bone age on X-ray is no more than 1 year ahead of real age.\n* Never taken growth hormone, IGF-1, or any ghrelin-like medicine before.\n* Both the subject and their guardian are able to voluntarily sign the Informed Consent Form (ICF) and voluntarily cooperate in completing the trial according to the protocol. If the subject is legally incompetent, written informed consent from their guardian shall be obtained. Additionally, relevant information about the clinical trial shall be communicated to the subject within their understanding, and the subject should be encouraged to sign the ICF personally as much as possible.\n\nExclusion Criteria:\n\n* Severe allergy to growth hormone or its ingredients.\n* Growth-hormone deficiency.\n* Any chromosome\u002Fgenetic\u002Fsyndrome cause of short stature.\n* Other diseases that can impair growth.\n* Cognitive, developmental, or psychiatric disorders that could affect assessments .\n* Current or past cancer, or high familial cancer risk.\n* Positive hepatitis B, hepatitis C, HIV, or active tuberculosis at screening.\n* Abnormal liver or kidney blood tests.\n* Pre-diabetes or diabetes at screening .\n* Systemic steroids \\> 28 consecutive days or \\> 14 days total in the last 3 months.\n* High-dose inhaled steroids \\> 28 days in the last year.\n* Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other drugs that affect growth. 13. Unable to receive subcutaneous injections.\n* Claustrophobia or inability to undergo brain MRI.\n* Participated in another clinical trial with investigational treatment within 3 months.\n* Any other condition that, in the investigator's opinion, makes the child unsuitable for the study.",{"count":366,"type":21},72,[129],"This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.",[370],"Short Stature Children Born Small for Gestational Age (SGA)",{"date":352,"type":37},{"date":373,"type":37},"2025-11-11",{"date":375,"type":21},"2027-04-30",{"name":43,"class":44},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":73},"100559870","phase-1-a-study-of-gensci098-in-subjects-with-active-thyroid-eye-disease-100559870","NCT06569758","A Study of GenSci098 in Subjects With Active Thyroid Eye Disease","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients","Inclusion Criteria:\n\n1. At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).\n2. Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.\n3. Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.\n4. Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.\n5. Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.\n6. Participants must be euthyroid with the underlying disease under control, or have mild hypo- or hyperthyroidism at screening. (Only applicable to Part 1)\n7. Participants must have normal thyroid function or hyperthyroidism due to GD at screening. (Only applicable to Part 2)\n8. No prior treatment with antithyroid medications and\u002For thyroid hormone replacement therapy, or having taken antithyroid medications and\u002For thyroid hormone replacement therapy on a stable dose, or having not been treated with antithyroid medications and\u002For thyroid hormone replacement therapy due to intolerable side effects.\n9. Anyone who will not be required to need or receive any immediate or planned surgical ophthalmological intervention, corrective surgery or orbital irradiation during the study.\n10. Female participants must meet one of the following conditions to be eligible for the study:\n\n    1. Infertile, defined as surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or bilateral oophorectomy) at least 6 weeks prior to administration or menopausal (spontaneous amenorrhea ≥ 12 months which is not caused by underlying diseases and confirmed by serum follicle stimulating hormone \\[FSH\\] level ≥ 40 mIU\u002FmL).\n    2. Fertile female participants agree, from the start of the screening visit until 300 day after the last dose, to consistently and correctly use one of the following acceptable methods of effective contraception:\n\n       1. Complete abstinence (based on the participant's preference and usual lifestyle).\n       2. Use of oral contraceptives (estrogen and progesterone), and being on a stable dose of the same contraceptive medication for at least 3 months prior to study treatment.\n       3. Injectable or implantable hormonal contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate \\\u003C 1%), such as a hormonal vaginal ring or transdermal hormonal contraception. 4) Vasectomized partner, with the procedure performed at least 6 months ago.\n11. Male participants must meet one of the following criteria to be eligible for the study:\n\n1\\) agree to use a condom plus an effective method of contraception (i.e., hormonal contraception initiated at least 30 days prior to administration; or placement of an IUD or IUS) when engaging in sexual activity with a female partner of childbearing potential from the start of the screening visit until 24 weeks after the last dose and refrain from donating sperm during this period.\n\n2\\) agree to practice abstinence from the start of the screening visit until 24 weeks after the last dose.\n\n3\\) have had a vasectomy at least 6 months prior to study treatment. 12. Voluntarily sign the ICF and be able to understand and comply with the study's treatment regimen and assessments until the end of the study\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.\n2. Corneal injury not relieved by medical management.\n3. Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.\n4. Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.\n5. Previous orbital irradiation or surgery for TED.\n6. Use of any steroid (either intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for TED within 4 weeks prior to screening (discontinued steroid eye drops arepermitted).\n7. Use of steroids for conditions other than TED within 4 weeks prior to screening (topical steroids for dermatological conditions and inhaled steroids are permitted).\n8. Drug therapy with biologics or peptides, including teprotumumab, rituximab, or tocilizumab, within 6 months or 5 half-lives of the drug (whichever is longer) prior to screening.\n9. Use of any non-steroidal immunosuppressive agents within the 3 months prior to screening.\n10. Pre-existing ophthalmic disease or autoimmune disease (other than TED) that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.\n11. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and\u002For current or previous history of thyroid storm. (Only applicable to Part 2)\n12. History of radioiodine treatment or thyroidectomy within 6 months prior to first dose. (Only applicable to Part 2)\n13. Individuals who cannot abstain from smoking\u002Ftobacco products from the screening period to the end of the study.\n14. Any known allergy to the components of the investigational product or analogues or previous allergic reactions to monoclonal antibodies.\n15. Known history \u002Fdiagnosis of malignancy.\n16. Acute\u002Fchronic infection within 2 weeks prior to screening.\n17. Participation in another clinical trial within 3 months before screening (except those who did not receive any intervention), or within 5 half-lives of the study drug in other clinical trials (whichever is longer), or concurrent enrollment in another clinical trial.\n18. Those with prolonged QTcF interval in 12-lead ECG results (\\> 450 ms for males, \\> 460 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening that, in the investigator's judgment, may affect trial participation;\n19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 3 times the ULN, or total bilirubin (TBIL) or alkaline phosphatase (ALP) \\> 2 × ULN, blood creatinine (Cr) ≥ 1.5 times the ULN at screening.\n20. Positive blood pregnancy test, or lactating women at the time of screening.\n21. Positive for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum particle agglutination (TPPA) test, or hepatitis B surface antigen (HbsAg) at screening.\n22. History of recreational drug use or substance abuse or positive drug screening results at screening.\n23. Any medical (including other clinically significant abnormal laboratory test parameters) or other conditions that the investigator believes might affect the conduct of the clinical trial.",{"count":385,"type":21},76,[24],"To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)",[29,30,348,389],"Thyroid Eye Disease (TED)","2026-02-09",{"date":392,"type":37},"2026-02-11",{"date":394,"type":37},"2024-09-24",{"date":396,"type":21},"2027-12-13",{"name":43,"class":44},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":73},"100620316","phase-3-nanocrystalline-megestrol-acetate-for-cachectic-stage-locally-advanced-hepatocellular-carcinoma-100620316","NCT07356037","Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma","A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone for Cachectic Stage Locally Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Patients with hepatocellular carcinoma who have not previously received systemic therapy and are confirmed by histological or cytological assessment, as evaluated by the investigator, to be unsuitable or ineligible for curative surgical resection; Barcelona Clinic Liver Cancer (BCLC) stage B-C.\n2. Child-Pugh class A or B7.\n3. Planned to receive interventional therapy in combination with systemic antitumor therapy.\n4. At least one measurable tumor lesion according to mRECIST v1.1.\n5. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).\n\nExclusion Criteria:\n\n1. Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.\n2. Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.\n3. Patients with acquired immunodeficiency syndrome (AIDS).\n4. Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n5. Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.","85 Years",{"count":57,"type":21},[408],"PHASE3","This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with standard therapy alone in improving appetite and body mass index (BMI) during treatment in patients with early-stage or locally advanced hepatocellular carcinoma at the cachexia stage.",[411,412],"Cachexia","Hepatocellular Carcinoma","2026-01-14",{"date":415,"type":37},"2026-01-21",{"date":417,"type":21},"2026-01-10",{"date":419,"type":21},"2027-12-31",{"name":43,"class":44},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100612348","phase-1-gensci143-in-participants-with-advanced-solid-tumors-100612348","NCT07252414","GenSci143 in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign the ICF.\n* Male or female participants ≥18 years old at the time of signing the ICF.\n* Meet the requirements of tumor types as outlined below:\n\n  1. Dose escalation: Participants with histologically or cytologically documented recurrent or metastatic advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard therapy, or have no standard therapy available.\n  2. Dose expansion:\n\nCohort 1: Participants with histologically or cytologically documented mCRPC，who had received at least one prior novel hormonal therapy (including but not limited to abiraterone, enzalutamide, darolutamide, apalutamide) and progressed on standard chemotherapy regimens, are intolerant to chemotherapy, or decline chemotherapy.\n\nCohort 2: Participants with histologically or cytologically documented other advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard treatment, or have no standard therapy available.\n\n* Life expectancy of ≥ 12 weeks.\n* ECOG PS 0-1\n* Have at least 1 evaluable tumor lesion according to RECIST v1.1. Participants with mCRPC who have bone only disease may be eligible on a case-by-case basis after discussion between the investigator and Sponsor\n* Able to provide either archival or fresh biopsy formalin-fixed paraffin-embedded (FFPE) tumor samples.\n* Adequate organ function at the time of screening, as outlined below:\n\n  1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (1500\u002FµL); platelet count (PLT)≥100×109\u002FL (100,000\u002FµL); hemoglobin (HGB) ≥ 90 g\u002FL (9 g\u002FdL) (have not received granulocyte colony-stimulating factor (G-CSF) within 7 days before the first dose of GenSci143, and have not received granulocyte-macrophage colony-stimulating factor (GM-CSF), blood transfusion, erythropoietin (EPO), platelet transfusion, thrombopoietin (TPO), or interleukin-11 (IL-11) within 14 days before the first dose of GenSci143).\n  2. Liver function: Serum total bilirubin (TBIL) ≤ 1.5 upper limit of normal (ULN), and serum TBIL≤ 3×ULN in the presence of liver metastasis or documented Gilbert syndrome. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN if no liver metastasis; ALT and AST≤ 5×ULN in the presence of liver metastasis.\n  3. Renal function: creatinine clearance (CLcr) ≥ 50 mL\u002Fmin as calculated using the Cockcroft-Gault formula.\n  4. Coagulation function: Prothrombin Time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (or within target range if on anticoagulation therapy).\n* Toxicities (other than alopecia) from previous anticancer therapy must have resolved to NCI-CTCAE v5.0 Grade ≤1.\n* Women of childbearing potential (WOCBP) must have a serum pregnancy test negative within 7 days before the first dose of GenSci143. WOCBP must agree to use highly effective contraceptive methods and must not donate or retrieve ova for personal use from the time of informed consent until 6 months after the last dose of GenSci143. Male participants must agree to use highly effective contraceptive methods and must not freeze or donate sperm from the time of informed consent until 6 months after the last dose of GenSci143.\n\nExclusion Criteria:\n\n* Participants with known spinal cord compression or active central nervous system (CNS) metastases, unless they are asymptomatic or have achieved post-treatment stability for \\>4 weeks and discontinued corticosteroids for \\>2 weeks before the first dose of GenSci143.\n* History of other known malignancies within the past 3 years.\n* Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci143.\n* Uncontrolled or clinically significant cardiovascular disease.\n* Uncontrolled pleural fluid, pericardial effusion, or ascites requiring drainage, and\u002For diuretics within 2 weeks before the first dose of GenSci143.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening. Any autoimmune, connective tissue, or inflammatory disorders with suspected pulmonary involvement.\n* Pregnant, breastfeeding, or planning to become pregnant.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Known human immunodeficiency virus (HIV) infection\n* Uncontrolled infection that requires systemic therapy with IV antibiotics, antivirals, or antifungals within 1 week before the first dose of GenSci143.\n* Major surgery (excluding diagnostic surgery), radiotherapy, and immunotherapy within 4 weeks before the first dose of medication; Chemotherapy or antibody therapy within 3 weeks; Endocrine therapy and small molecule-targeted therapy within 2 weeks or 5 half-lives(whichever is shorter). Androgen-deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues (either GnRH agonists or GnRH antagonists) was allowed for men with prostate cancer.\n* Received any live vaccine within 4 weeks before the first dose of GenSci143 or intend to receive a live vaccine during the study.\n* History of allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.\n* Prior treatment with a topoisomerase inhibitor or an ADC that consists of a topoisomerase inhibitor.\n* History of severe hypersensitivity reactions to GenSci143 and\u002For excipients in the drug product, or other monoclonal antibodies.\n* Any illness (uncontrolled hypertension, serious diabetes mellitus, thyroid disorders, and psychiatric disorders, etc.) or other conditions that are not eligible for inclusion based on the investigator's judgment.",{"count":429,"type":21},180,[24],"A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors",[433],"Advanced Solid Tumors","2025-12-30",{"date":436,"type":37},"2026-01-05",{"date":438,"type":37},"2025-12-20",{"date":440,"type":21},"2029-06-30",{"name":43,"class":44},9,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":73},"100585904","phase-1-a-phase-i-first-in-human-study-of-gensci128-in-patients-with-solid-tumors-harboring-a-tp53-y220c-mutation-100585904","NCT06908434","A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation","A Phase I, Multicenter, Multinational, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation","Inclusion Criteria:\n\n1. Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)\n2. Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures\n3. Has confirmed TP53 Y220C mutation in tumor tissue\n4. Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.\n5. Has at least one measurable lesion by RECIST v1.1\n6. Has an ECOG status of 0 or 1\n7. Has a life expectancy of ≥ 3 months.\n\nExclusion Criteria:\n\n1. Has diagnosed as primary central nervous system (CNS) tumor.\n2. Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.\n3. Has a history of leptomeningeal disease or spinal cord compression.\n4. Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.\n5. Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.\n6. Uncontrolled hypertension (Blood pressure ≥ 150\u002F90 mmHg despite optimal medical management)\n7. Has a history of prior organ transplant or allogeneic stem cell transplant.\n8. Has received a selective reactivator of p53 Y220C mutation.\n9. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).\n10. Has known human immunodeficiency virus (HIV) infection (positive HIV 1\u002F2 antibodies) or known chronic hepatitis B or C \\[participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA; participants positive for hepatitis C virus (HCV) IgG will be eligible if they are negative for HCV-RNA\\].\n11. Is persisting toxicity related to prior anticancer therapy (NCI CTCAE V5.0 Grade\\>1). However, alopecia and sensory neuropathy Grade ≤2, or other Grade ≤2 adverse events not constituting a safety risk, based on the investigator's judgment are acceptable.\n12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or GenSci128 administration or may interfere with the interpretation of study results, in the judgment of the investigator, would make the participant inappropriate for entry into this study.",{"count":451,"type":21},82,[24],"The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation",[455],"Solid Tumors Harboring a TP53 Y220C Mutation","2025-12-23",{"date":434,"type":37},{"date":459,"type":37},"2025-06-10",{"date":461,"type":21},"2028-10",{"name":43,"class":44},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":73},"100610699","phase-1-gensci139-in-patients-with-advanced-solid-tumors-100610699","NCT07230977","GenSci139 in Patients With Advanced Solid Tumors","A Phase I, Two-Part, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activities of GenSci139 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci139 and any study procedures).\n* Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.\n* Adult participants (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.\n* Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and if not available, providing other archival tumor tissue specimens or not may be enrolled after discussion with sponsor.\n* Has at least one measurable lesion by RECIST v1.1.\n* Has an eastern cancer collaboration group (ECOG) status of 0 or 1.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Has a life expectancy of ≥ 3 months.\n* Has adequate hematologic and organ function prior to initiation dose of GenSci139.\n* Women of childbearing potential (WOCBP) must be willing to use adequate contraception while receiving GenSci139, and within 6 months after the last dose of GenSci139 and have a negative serum human chorionic gonadotropin (HCG) test.\n* Nonsterile males must be willing to use adequate contraception for the duration of receiving GenSci139 and within 6 months after the last dose of GenSci139.\n* Has histologically or cytologically confirmed locally advanced or metastatic UC, HNSCC, TNBC, NSCLC, BTC, ESCC, GC, CRC, OC, NPC, PDAC etc. and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.\n\nKey Exclusion Criteria:\n\n* Any active malignancy within 3 years before initiation dose of GenSci139 except for the cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), carcinoma in situ of the cervix or breast).\n* Has diagnosed as primary central nervous system (CNS) tumor.\n* Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 4 weeks prior to initiation dose of GenSci139.\n* Has a history of leptomeningeal disease or spinal cord compression.\n* Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci139.\n* Active autoimmune diseases and inflammatory diseases.\n* Has a history of (non-infectious) interstitial lung disease (ILD) \u002F pneumonitis that required steroids, has current ILD \u002F pneumonitis, or where suspected ILD \u002F pneumonitis cannot be ruled out by imaging at screening.\n* Unstable thrombotic events within 6 months prior to initiation dose of GenSci139.\n* Has severe chronic or active infection\n* Uncontrolled hypertension\n* Has clinically significant cardiovascular disease\n* Known severe hypersensitivity to GenSci139 and\u002For any of its excipients.\n* Has a history of severe hypersensitivity reactions to other monoclonal antibodies\n* With enough washout period to some therapies specified in protocol.\n* Known HIV infection, active HBV or HCV infection.\n* Has unresolved toxicities from previous anticancer therapy\n* Had received HER2 or EGFR monoclonal antibodies, or using TOPO I inhibitor as payload, targeted to HER2 or EGFR ADC, and could not be intolerance of those treatment.\n* Women who are pregnant or lactating or are planning to become pregnant.\n* Uncontrollable pleural effusion, pericardial effusion, or abdominal and pelvic effusion requiring drainage and\u002For diuretics within 14 days prior to GenSci139 infusion.\n* The other conditions of participation in this clinical trial were not considered appropriate by the investigators.",{"count":471,"type":21},280,[24],"This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.",[433],"2025-12-18",{"date":477,"type":37},"2025-12-24",{"date":479,"type":37},"2025-11-19",{"date":481,"type":21},"2029-01-08",{"name":43,"class":44},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":73},"100612252","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-gensci140-in-participants-with-advanced-solid-tumors-100612252","NCT07251166","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors","A Multi-center, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of GenSci140 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Those who are able to understand and willing to sign written Informed Consent Form.\n2. Aged between 18 and 75 years (inclusive) when signing the ICF\n3. Participants with advanced solid tumors\n4. The participant agrees to provide fresh biopsy or archived tumor tissues for testing by the central laboratory.\n5. At least one evaluable lesion in the dose-escalation part, and at least one measurable lesion in the dose-expansion part.\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n7. Life expectancy ≥ 3 months.\n8. Adequate hematologic and organ function before the first dose of GenSci140.\n9. All toxicities related to prior anti-tumor therapies must have resolved to Grade ≤ 1, with the following exceptions: alopecia, peripheral neurotoxicity (must have resolved to Grade ≤ 2).\n10. For participants with congestive heart failure (CHF), it must be Grade ≤ 1 in severity and must have recovered completely prior to enrollment.\n11. Normal QT interval on electrocardiogram (ECG) evaluation at screening\n12. Participants who test negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).\n13. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. WOCBP must agree to avoid pregnancy.\n14. Men with female partners of childbearing potential must take appropriate precautions to avoid pregnancy of partner and use appropriate barrier contraceptives or abstinence\n\nExclusion Criteria:\n\n1. Past history of cancers.\n2. Symptomatic primary central nervous system (CNS) tumors, metastases, leptomeningeal carcinomatosis, or therapy naive spinal cord compression.\n3. Use of an investigational medicinal product (IMP) or antitumor therapy (including chemotherapy, biologic therapy, immunotherapy) within 5 half-lives or 4 weeks before the first dose of GenSci140. Concomitant anti-tumor therapy is not permitted\n4. Major surgery within 4 weeks prior to the first dose of GenSci140.\n5. Radiotherapy for ≥ 20% of bone marrow or large area of radiotherapy within 4 weeks prior to the first dose of GenSci140. Or participants have not recovered from acute effects of radiotherapy to baseline prior to the first dose of GenSci140.\n6. Clinically significant active cardiovascular disorder or history of myocardial infarction within 6 months prior to the first dose of GenSci140.\n7. Uncontrolled active systemic bacterial, viral, or fungal infection or ongoing serious systemic disease, such as hypertension or diabetes, despite Best Supportive Care. Chronic disease screening is not required.\n8. History of multiple sclerosis or other demyelinating diseases, Eaton-Lambert syndrome (paraneoplastic syndrome), alcoholic liver disease, history of internal haemorrhage or ischemic stroke within the past 6 months, haemorrhagic diathesis that are unsuitable for enrollment as assessed by the investigator.\n9. Suspected treatment-related pneumonitis that was clinically diagnosed in the past and currently requires steroids or cannot be ruled out by imaging at screening.\n10. Uncontrolled pleural effusion, pericardial effusion, or abdominal and pelvic fluid collection requiring drainage and\u002For diuretics within 14 days prior to the first dose of GenSci140.\n11. Pregnant or lactating women.\n12. Known hypersensitivity to prior monoclonal antibody therapy.\n13. Patients who previously underwent allogeneic or autologous bone marrow transplantation.\n14. Participants whom the investigator deems unsuitable for enrollment in this clinical study",{"count":491,"type":21},170,[24],"This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).",[433],{"date":477,"type":37},{"date":497,"type":37},"2025-12-10",{"date":145,"type":21},{"name":43,"class":44},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":73},"100616163","phase-1-a-first-in-human-safety-and-pharmacokinetic-trial-of-gensci142-administered-as-single-ascending-doses-in-healthy-chinese-women-100616163","NCT07302035","A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women","A Phase Ia Single-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Trial of GenSci142 Administered in Single Ascending Doses in Healthy Chinese Women","Inclusion Criteria:\n\n* Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF);\n* Sexually active and willing to undergo vaginal administration of the study product；participants must agree to avoid the use of other intravaginal products (e.g., contraception ointments, gels, foams, sponges, lubricants, irrigation solutions, tampons, etc.) throughout the trial;\n* During the screening period, there are no clinically significant abnormalities in medical history, vital signs, physical examination, gynecological examination, laboratory test (hematology, routine urinalysis, clinical chemistry, coagulation function, vaginal microbiome test) and 12-lead ECG, or any out-of-range laboratory values or other findings must be assessed by the investigator as not clinically significant;\n\nExclusion Criteria:\n\n* Those experiencing stinging or burning sensation, hemorrhage, pruritus, erythema, edema, or increased discharge due to previous or current use of vaginal preparations, or those with any factors that possibly have an impact on evaluation of administration site irritation, or those with other factors that may have an impact on vaginal administration, such as genital malformation;\n* Serious infections, chronic infections, opportunistic infections, etc. within 3 months prior to screening, and infections treated with systemic antimicrobial drugs (including but not limited to viruses, bacteria, fungi, and parasitic infections) within 4 weeks prior to randomization;\n* Surgical history: a. vaginal, pelvic or cervical surgery within 90 days prior to screening or planning to undergo surgery during the study; b. hysterectomy; c. other major surgery within 30 days prior to screening or planning to undergo other surgeries during the study;","55 Years",{"count":20,"type":21},[24],"This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.",[32],[513,514,515,516,517,518,519,520],"Bacterial Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Gardnerella spp.","Gardnerella vaginalis","GenSci142",{"date":477,"type":37},{"date":523,"type":21},"2025-12",{"date":525,"type":21},"2026-12",{"name":43,"class":44},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":54,"minAge":300,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":73},"100613285","phase-1-a-study-phase-1b2-of-gs3-007a-oral-treatment-in-children-with-growth-hormone-deficiency-pghd-100613285","NCT07264595","A Study (Phase 1b\u002F2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)","A Study to Evaluate the Safety and Tolerability of Multiple Ascending Doses of GS3-007a Dry Suspension in Patients With PGHD and to Evaluate the Efficacy and Safety of 52-week of Treatment With GS3-007a Dry Suspension: a Two-part, Multicenter, Randomized, Phase Ib\u002FII Clinical Trial","Inclusion Criteria:\n\n* chronological age (CA) ≥3 years at Screening\n* Prepubertal girls or boys\n* Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD)\n* A confirmed diagnosis of growth hormone deficiency (GHD)\n* Having not been treated with any growth-promoting drugs\n* BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period)\n* Subjects who have completed the 52-week treatment period of phase II\n* Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II\n\nExclusion Criteria:\n\n* A highly allergic constitution\n* Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH\n* Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth\n* Congenital skeletal dysplasia or serious spinal anomalies\n* Cognitive hypofunction, neurodevelopmental disorders, or psychiatric\u002Fpsychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth\n* Concurrent use of any medications that may affect growth or response to growth hormone therapy\n* Epiphyseal closure\n* Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT\u002FQTc interval prolonged\n* Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period)\n* Subjects with closed epiphyses\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Known or suspected allergy to the IMP\n* Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit",{"count":535,"type":21},88,[24,129],"This is a two-part clinical study for children with growth hormone deficiency. In the first part, participants will be randomly assigned to receive different doses of an oral treatment (GS3-007a dry suspension) or a placebo for 14 days. This part is double-blinded, meaning neither the participants nor the doctors will know who is receiving the treatment or placebo. The goal is to find a safe and well-tolerated dose.\n\nIn the second part, participants will be randomly assigned to receive either the selected dose of GS3-007a or another approved treatment for 52 weeks. This part is open-label, so everyone will know which treatment is being given. After that, all participants may continue taking GS3-007a for another 156 weeks in an extension phase to study long-term effects.",[307],[540,310],"GS3-007a dry suspension","2025-11-24",{"date":543,"type":37},"2025-12-04",{"date":523,"type":21},{"date":546,"type":21},"2030-11",{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":405,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":566,"locationsCount":73},"100611653","phase-4-a-prospective-real-world-observational-study-of-nanocrystalline-megestrol-acetate-in-patients-with-cancer-cachexia-100611653","NCT07243379","A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia","Inclusion Criteria:\n\n* Patients with histologically and\u002For cytologically confirmed malignancy.\n* Age ≥18 years at enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and an expected survival of ≥3 months.\n* Meeting the diagnostic criteria for cachexia (based on Fearon's criteria).\n* Body mass index (BMI) ≤30.\n\nExclusion Criteria:\n\n* Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.\n* Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.\n* Patients with acquired immunodeficiency syndrome (AIDS).\n* Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n* Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.",{"count":555,"type":21},495,[557],"PHASE4","This study is a prospective, real-world observational study. The objective is to evaluate the effectiveness and safety of nanocrystalline megestrol acetate in patients with cancer cachexia in real-world settings. Eligible participants were patients diagnosed with cancer cachexia who were scheduled to receive treatment with nanocrystalline megestrol acetate.",[560,561],"Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia","Multicenter Observational Study",{"date":354,"type":37},{"date":564,"type":37},"2025-09-25",{"date":271,"type":21},{"name":43,"class":44},""]