[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tolerability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tolerability":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,71,93,115,139,160,186,213,235,258],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29,30,31],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":20},"2026-06-15",{"date":40,"type":20},"2027-05-05",{"name":42,"class":43},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":16,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"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.",true,"ALL","70 Years",{"count":56,"type":20},64,[23],"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.",[28,29,60],"Adult Growth Hormone Deficiency","RECRUITING","2026-04-12",{"date":64,"type":36},"2026-04-14",{"date":66,"type":36},"2025-06-09",{"date":68,"type":20},"2026-11-25",{"name":42,"class":43},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":70},"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":79,"type":20},24,[23],"To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease",[28,29,83,84],"GenSci098","Graves Disease","2026-02-13",{"date":87,"type":36},"2026-02-17",{"date":89,"type":36},"2025-11-21",{"date":91,"type":20},"2027-03-18",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":70},"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.","75 Years",{"count":102,"type":20},76,[23],"To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)",[28,29,83,106],"Thyroid Eye Disease (TED)","2026-02-09",{"date":109,"type":36},"2026-02-11",{"date":111,"type":36},"2024-09-24",{"date":113,"type":20},"2027-12-13",{"name":42,"class":43},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100534786","phase-1-phase-12-study-of-hyp-2090ptsa-in-patients-with-advanced-solid-tumors-harboring-kras-mutation-100534786","NCT06243354","Phase 1\u002F2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation","An Open-label, Multi-center, Multi-cohort, Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* 18 Years and older;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* Expected survival ≥ 3 months;\n* Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\nExclusion Criteria:\n\n* Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;\n* Patients who have received live vaccines within 4 weeks prior to the first dose;\n* Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;\n* Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism\u002Fhemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;\n* Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;\n* Patients who have previously received allogeneic tissue\u002Fsolid organ transplantation;\n* Patients with active infection;\n* Patients who are positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL) or active hepatitis C (HCV antibody positive and HCV-RNA \\> lower limit of detection by the research center);\n* Female subjects who are lactating or have a positive blood\u002Furine pregnancy result during the screening period;\n* Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.",{"count":123,"type":20},257,[23,125],"PHASE2","This is a multicenter, open-label phase 1\u002F2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[28,29,128],"Efficacy","2026-01-27",{"date":131,"type":36},"2026-01-29",{"date":133,"type":36},"2024-02-04",{"date":135,"type":20},"2026-12",{"name":137,"class":43},"Sichuan Huiyu Pharmaceutical Co., Ltd",6,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":70},"100565213","phase-1-phase-12-clinical-study-of-hy07121-powder-for-solution-for-infusion-in-patients-with-advanced-solid-tumors-100565213","NCT06639256","Phase 1\u002F2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","An Open-label, Multiple-center, Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Written informed consent;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;\n* Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Within the defined washout periods for prior anti-cancer treatments;\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.\n* Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).\n* Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;\n* Major surgery within 4 weeks of receiving the first dose of study treatment;\n* Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;\n* Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;\n* Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;\n* Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS);\n* Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;\n* Active known or suspected autoimmune disease.\n* History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;\n* History of severe allergy;\n* History of allogeneic organ transplantation or graft-versus-host disease;\n* Have received live\u002Fattenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live\u002Fattenuated vaccines and mRNA vaccines during the study period;\n* Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;\n* Known psychiatric disorder or drug abuse that would interfere the trial requirements;\n* Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;\n* In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);\n* Participants considered unsuitable for participation in this study by the investigators.","80 Years",{"count":148,"type":20},258,[23,125],"This is a multi-center, open-label, phase 1\u002F2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)\u002Fpharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.",[28,29,128],"2026-01-26",{"date":154,"type":36},"2026-01-28",{"date":156,"type":36},"2024-10-24",{"date":158,"type":20},"2026-10",{"name":137,"class":43},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":52,"sex":53,"minAge":16,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100614928","phase-1-a-first-in-human-sad-and-mad-study-in-healthy-participants-to-evaluate-oral-yr011-tablet-100614928","NCT07285967","A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet","A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.","Inclusion Criteria:\n\n* Participants who meet all the following criteria could be enrolled in this study:\n\n  1. Written informed consent obtained from the participant in compliance with all local legal requirements.\n  2. Male or female participant aged between 18 and 60 years (extremes included).\n  3. Body mass index (BMI) between 18-32 kg\u002Fm2 (extremes included) and body weight less than 120 kg.\n  4. Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.\n  5. Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.\n  6. Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.\n  7. Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.\n\nExclusion Criteria:\n\n* If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:\n\n  1. Pregnant or lactating women.\n  2. Participants with dysphagia.\n  3. Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.\n  4. Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.\n  5. History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n  6. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  7. Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)\\\u003C90 mL\u002F min).\n  8. Presence of hepatic impairment: Child-Pugh A, B or C and\u002For transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels \\> ULN).\n  9. diagnosis of diabetes regardless the degree of control at screening visit\n  10. Hyperthyroidism or hypothyroidism.\n  11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.\n  12. Any major surgery within 6 months of screening.\n  13. Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I\u002FII), Treponema Pallidum antibody (positive anti-TP) at screening.\n  14. Participants with innate or acquired immune system defects.\n  15. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  16. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.\n  17. Participant has a QT interval with Fridericia's correction method (QTcF) \\>450 ms (males) or\\>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT\u002FQTc interval.\n  18. Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.\n  19. Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal \\[including traditional Chinese medicinal products\\] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration. etc.","60 Years",{"count":56,"type":20},[23],"This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.\n\nThe trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.\n\nKey procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.\n\nThe trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.",[28,29,30],[173,174,175,176],"KV1.3","YIRUI pharma","yirui","Healthy Volunteers","2025-12-18",{"date":179,"type":36},"2025-12-26",{"date":181,"type":20},"2026-04-01",{"date":183,"type":20},"2026-12-31",{"name":185,"class":43},"Hangzhou Yirui Pharmaceutical Technology Co., Ltd",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":52,"sex":53,"minAge":16,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":70},"100573887","phase-1-safety-tolerability-and-pharmacokinetics-of-rcs-21-in-healthy-volunteers-100573887","NCT06752122","Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.","Safety, Tolerability and Pharmacokinetics of Single-ascending Doses of RCS-21 in Healthy Volunteers. A Double Blind, Randomized, Placebo Controlled Phase I Study.","AMIR-21","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male or female aged 18 to 64 years (inclusive).\n3. Women will be considered for inclusion if they are:\n\n   * Not pregnant, as confirmed by pregnancy test (see assess- ment schedule), and not breastfeeding. AND\n   * WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly\n\n     * according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 30 days after the last administration of study medication:\n\n       * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * intravaginal\n         * transdermal\n       * progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * injectable\n         * implantable\n       * intrauterine device (IUD)\n       * intrauterine hormone-releasing system (IUS)\n       * bilateral tubal occlusion\n       * vasectomized partner (provided that this partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical as- sessment of the surgical success)\n       * sexual abstinence (defined as refraining from hetero- sexual intercourse during the entire study period, be- ginning 2 weeks prior to the screening visit) OR\n   * Of non-childbearing potential defined according to the Clinical Trial Facilitation Group (CTFG) document \"Recommendations related to contraception and pregnancy testing in clinical trials\"\n4. Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 30 days after the last administra- tion of study medication:\n\n   * Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.\n   * Male participants are required to use a condom during treatment and until 30 days after the last administration of study medication.\n   * Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 30 days after the last administration of study medication.\n   * Sperm donation is not allowed during treatment and until 30 days after the last administration of study medication.\n5. Healthy participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead Electrocardiogram (ECG), pulmonary function testing and clinical laboratory tests.\n6. Body Mass Index (BMI) of 18.5 to 31.9 kg\u002Fm2 (inclusive).\n7. Ability to inhale in an appropriate manner (e.g. as confirmed in the inhalation training using the PARI eFlow® device with a pla- cebo medication at the screening visit).\n8. Non-smokers (including e-cigarette) or ex-smokers (with less than 10 pack years and stopped smoking for at least 5 years prior to screening visit).\n9. Normal pulmonary function with Forced Expiratory Volume in the first second (FEV1) ≥ 80 % of predicted normal at screening visit. Calculations will be based on the Global Lung Function Initiative (GLI 2012) formula.\n\nExclusion Criteria:\n\n1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study or may influence the results of the study, or the participant's ability to participate in the study.\n2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, he- patic disease (asymptomatic Gilbert syndrome is allowed), renal disease, hematological disease, neurological disease, endo- crine disease (stable and asymptomatic hypothyroidism with or without Hormone Replacement Therapy (HRT) is allowed) or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).\n3. Having received any vaccination within the last 2 weeks before the first screening visit.\n4. History or current evidence of clinically relevant allergies or idiosyncrasy to any drug or food.\n5. History of allergic reactions to any active or inactive component of the study medication (including medication for bronchoscopy, e.g. salbutamol, lidocaine, midazolam or propofol).\n6. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).\n7. Proneness to orthostatic dysregulation, fainting, or blackouts.\n8. History or presence of any malignancy except for basalioma.\n9. Chronic or acute infections or history of an acute infection during the four weeks before the first screening visit.\n10. Positive results in any of the following virology tests: human im- munodeficiency virus (HIV) antibodies and antigen, Anti-hepati- tis B-core antibody (HBc-Ab), hepatitis B-surface antigen (HBs- Ag) and anti-hepatitis C virus antibody (HCV-Ab).\n11. Positive drug screen (amphetamines, barbiturates, benzodiaze- pines, cannabinoids, cocaine, methadone, methamphetamine, opiates, phencyclidine, or tricyclic antidepressants).\n12. History of previous administration of any registered or investiga- tional oligonucleotide-based drug.\n13. History or presence of alcohol or drug abuse.\n14. Use of any medication (including over-the-counter medication, herbal products) except allowed concomitant medication within 2 weeks (for biologics: 6 months) before administration of IMP or within \\< 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer.\n15. Positive breath alcohol test.\n16. Planned donation of oocytes, blood, organs, bone marrow dur- ing the course of the study or within 6 months after the last screening visit.\n17. Participation in another clinical study with an investigational drug or device within the last 3 months or during the course of the study. For biologics, the minimum exclusion period is at least 6 months or the time of duration of the pharmacodynamic effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this study.\n18. Blood donation of more than 250 ml within the last 30 days before the first screening visit.\n19. Anticipated non-availability for study visits\u002Fprocedures.\n20. Anticipated lack of willingness or inability to cooperate adequately.\n21. Vulnerable participants, except WOCBP.","64 Years",{"count":79,"type":20},[23],"The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose of RCS-21 and their health status will be constantly monitored.",[176,28,29,30],[200,201,202,203],"RCS-21","Phase I","Healthy volunteers","Inhalation","2025-11-17",{"date":206,"type":36},"2025-11-20",{"date":208,"type":36},"2025-02-18",{"date":210,"type":20},"2026-08",{"name":212,"class":43},"RNATICS GmbH",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":44},"100450215","phase-1-phase12a-study-for-ipg7236-in-patients-with-advanced-solid-tumors-100450215","NCT05142592","Phase1\u002F2a Study for IPG7236 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. A written informed consent must be signed prior to performing any study procedures.\n2. Male or females 18 years or older.\n3. Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.\n\n   * Part 1 Dose Escalation: all solid tumor types.\n   * Part 2 Dose Expansion: the following tumor types are tentatively planned for expansion. It may be modified based on the results from the dose escalation phase.\n\n     * Renal cancer\n     * Triple-negative breast cancer\n     * Head and neck cancer\n     * Melanoma\n4. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds.\n5. Subjects must demonstrate measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n6. Subjects must have a life expectancy of ≥ 3 months.\n7. Subjects must have an Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1.\n8. Subjects must have adequate hematologic and organ function as indicated by the following laboratory values\n\n   1. Hematologic\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n      * Platelet count ≥ 100×109\u002FL\n      * Hemoglobin ≥ 9 g\u002FdL (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g\u002FdL)\n   2. Renal\n\n      • Estimated glomerular filtration rate（eGFR ）≥ 50 mL\u002Fmin OR serum creatinine ≤ 1.5 × upper limit of normal (ULN).\n   3. Hepatic\n\n      * Aspartate aminotransferase levels ≤ 3 ×ULN (if liver metastases are present, ≤ 5× ULN)\n      * Alanine aminotransferase levels ≤ 2.5 × ULN (if liver metastases are present, ≤ 5×ULN).\n      * Bilirubin ≤ 1.5 × ULN\n   4. Coagulation • Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN\n9. Subjects must be able to swallow and retain orally administered medication.\n10. Patients must be willing and able to comply with all scheduled visits, treatment, laboratory tests, be able to take oral medication, and other requirements of the study\n11. Female patients of child-bearing potential must have a negative pregnancy test.\n12. Female patient who is of child-bearing potential is eligible to participate but must use an acceptable form of birth control method, including abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), diaphragm with spermicide, cervical cap, condoms with contraceptive gel\u002Ffoam \u002Fcream, or surgical sterilization (tubal ligation at least 6 months prior to screening) or partner who had a vasectomy at least 6 months prior to screening\n13. Male patient with a female partner of child-bearing potential is eligible to participate but must be either documented to be surgically sterile (vasectomy), practicing complete abstinence for 90 days after study drug administration, or using two adequate forms of highly effective contraception (together with the female partner), one of which should be a physical barrier method, for 90 days after the study drug administration.\n\nExclusion Criteria:\n\n1. Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.\n2. Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.\n3. Subjects with recent prior therapy defined as\n\n   1. Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.\n   2. Any radiotherapy, chemotherapy, targeted therapy or immunotherapy within 14 days or major surgery within 28 days or anti-neoplastic antibody or nitrosoureas\u002Fmitomycin C within 42 days prior to the first dose of study drug\n4. Subjects with any uncontrollable diseases (e.g., severe mental, neurological, cardiovascular, respiratory, and other systemic diseases) or obvious active infections that may affect the clinical study.\n5. Subjects with positive Coronavirus disease（COVID）-19 PCR tests (patients who recovered from COVID-19 but have positive COVID-19 PCR tests may be included at the judgment of the Investigator)\n6. Subjects who have received the live or attenuated vaccine within 4 weeks prior to study treatment or intend to receive a live or attenuated vaccine during the study\n7. Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment. History of known HIV infection.\n\n   Note:\n   1. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) is obtained.\n   2. Subjects with well-controlled HIV may be enrolled if all the following criteria are met:\n\n      * must be stable on their anti-retroviral regimen, and participants must be healthy from an HIV perspective\n      * Participants must have a cluster of differentiation 4（CD4） count of greater than 250 cells\u002Fmicro litre（mcL ）over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FmcL over the past 2 years unless it was deemed related to THE CANCER AND\u002FOR CHEMOTHERAPY-induced bone marrow suppression\n\n        \\- For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FmcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n      * Participants must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FmcL within 7 days of enrollment\n      * Participants must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts\n8. Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent may be included at the judgment of the Investigator.\n9. Subjects with symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for \\>1 month, are asymptomatic and off corticosteroids, or are on a stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. The stability of brain metastases must be confirmed with imaging. The subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post procedure complications or the subject is stable.\n10. Subjects with active upper digestive tract ulcer or other disorders that can affect drug absorption, distribution, metabolism or clearance.\n11. Subjects with a marked baseline prolongation of QT\u002Fcorrected QT interval（QTc） interval (e.g., repeated demonstration of a QTc interval \\>480 milliseconds (CTCAE grade 1) using Fridericia QT correction formula.\n12. Subjects using concomitant medications known to prolong the QT\u002FQTc interval.\n13. Pregnancy or breastfeeding female; Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.\n14. Subjects who are unable to comply with study and follow-up procedures",{"count":221,"type":20},196,[23,125],"This is a Phase 1\u002F2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.\n\nThe study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).\n\nEach part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.",[225,29,30],"Safety Issues","2025-09-22",{"date":228,"type":36},"2025-09-24",{"date":230,"type":36},"2021-11-15",{"date":232,"type":20},"2025-12-21",{"name":234,"class":43},"Nanjing Immunophage Biotech Co., Ltd",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":52,"sex":53,"minAge":16,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":70},"100581237","phase-1-single-ascending-dose-and-multiple-ascending-dose-study-of-avr-48-100581237","NCT06847698","Single Ascending Dose and Multiple Ascending Dose Study of AVR-48","Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form (ICF).\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Healthy adult male or female, aged 18 to 55, inclusive, at Screening.\n4. Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study\n5. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg\u002Fm2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening.\n6. Medically healthy with no clinically significant abnormalities in medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.\n7. If female of childbearing potential, must be consistently using an effective method of contraception from screening visit until 30 days after the last drug administration.\n8. If female and not of childbearing potential, must be either surgically sterile or post menopausal (i.e., more than 1 year since last menstrual period).\n9. A non-vasectomized, male subject must agree to use an effective method of birth control with female partners of childbearing potential during the study and to refrain from donating sperm for 90 days following dosing.\n10. No restrictions are required for a vasectomized male subject provided his vasectomy has been performed 4 months or more (and have official documentation) prior to Study Day 1. A subject who has been vasectomized less than 4 months prior to Study Day 1 or does not have official documentation of his vasectomy must follow the same restrictions as a non-vasectomized subject.\n\nExclusion Criteria:\n\n1. Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n5. Has had surgery or any medical condition within 6 months prior to first dosing which may affect the distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.\n6. Female subjects with a positive pregnancy test or who are lactating.\n7. Positive urine drug or alcohol results at screening or first check-in.\n8. Positive cotinine results at screening.\n9. Positive result at screening for tuberculosis (i.e., positive result for QuantiFERON TB-Gold).\n10. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n11. Unable to refrain from or anticipates the use of:\n\n    • Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Hormone replacement therapy will be allowed.\n12. Donation or loss of 50 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days prior to the first dosing.\n13. Plasma donation within 14 days prior to the first dosing.\n14. Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.\n15. Had a treatment with other investigational drug within 5 times the terminal elimination half-life (t1\u002F2), if known (e.g., a marketed product) or within 30 days (if the t1\u002F2 is unknown), whichever is longer, prior to Study Day 1 dosing.\n16. Evidence of Coronavirus Disease 2019 (COVID-19) infection.","55 Years",{"count":244,"type":20},48,[23],"This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.",[225,29,30,248],"Pharmacodynamics","2025-04-03",{"date":251,"type":36},"2025-04-06",{"date":253,"type":20},"2025-06",{"date":255,"type":20},"2025-11",{"name":257,"class":43},"AyuVis Research, Inc.",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":100,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100557513","phase-3-fluzoparib-in-combination-with-apatinib-mesylate-for-maintenance-therapy-in-stage-iii-iv-ovarian-cancer-100557513","NCT06539091","Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer","A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)","Inclusion Criteria:\n\n* ECOG PS: 0-1;\n\n  * Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;\n\n    * No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.\n\nExclusion Criteria:\n\n* Patients concurrently enrolled in other clinical trials;\n\n  * Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;\n\n    * Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;\n\n      * Previous significant allergy to drugs or food or other substances;\n\n        * Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose \\>10mg\u002Fday prednisone or other isotonic hormones) has been discontinued for \\>2 weeks without clinical evidence;\n\n          * Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;\n\n            * Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);\n\n              * Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;\n\n                * Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence \\> 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.",{"count":266,"type":20},51,[268],"PHASE3","This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.\n\nPatients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.\n\nThe study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.",[271,128,28,272,29],"Epithelial Ovarian Cancer","Bone Mineral Density","2024-08-03",{"date":275,"type":36},"2024-08-06",{"date":277,"type":20},"2024-10-01",{"date":279,"type":20},"2026-10-01",{"name":281,"class":282},"Anhui Provincial Hospital","OTHER_GOV"]