[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Kexing Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100624192","phase-1-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-gb10-intravitreal-injection-in-patients-with-neovascular-age-related-macular-degeneration-namd-100624192",false,"NCT07406438","To Evaluate the Safety, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","An Open-label, Multicenter, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Key Inclusion Criteria:\n\n1. Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred \\> 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).\n2. The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);\n3. CNV lesion of all types (CNV lesion types in the study eye include predominantly classic, minimally classic, or occult \\[including polypoidal choroidal vasculopathy (PCV)\\]) with:\n\n   1. Total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas by FFA;\n   2. CNV component area of ≥ 50% of total lesion size by FFA;\n   3. Active CNV confirmed by FFA (evidence of leakage);\n   4. CNV exudation confirmed by SD-OCT (presence of fluid).\n4. BCVA letter score in the study eye of 78-24 letters (inclusive) in ETDRS-like charts (20\u002F32-20\u002F320 Snellen equivalent) before the first dose;\n5. Willingness to participate in the study, to comply with the study protocol, and to provide signed informed consent.\n\nKey Exclusion Criteria:\n\n1. CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;\n2. The study eye on FFA:\n\n   1. Subretinal hemorrhage of \\> 50% of the total lesion area and\u002For that involves the fovea; or\n   2. Fibrosis or atrophy of \\> 50% of the total lesion area and\u002For that involves the fovea;\n3. Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy \\[CSC\\], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;\n4. Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in the study eye (for study eye with prior refractive surgery or cataract surgery, preoperative refractive error demonstrating more than 8 diopters), or axial length \\>26.5 mm when reliable refractive assessment is unavailable;\n5. Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as IOP≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye;\n6. Current or prior receipt of any treatment for the study eye, including but not limited to:\n\n   1. IVT implantation or injection other than anti-VEGF drugs within 6 months before screening (e.g., steroids, transplasminogen activator, ocriplasmin, C₃F₈ gas, air filling);\n   2. Periocular pharmacological interventions for retinal diseases within 6 months before screening (including subconjunctival, sub-tenon's, peribulbar, or retrobulbar injections);\n   3. Laser\u002Fphotodynamic therapies within 6 months before screening (including laser photocoagulation, verteporfin PDT, diode laser, or transpupillary thermotherapy);\n   4. Cataract surgery within 3 months before screening, or corticosteroid treatment for complications of cataract surgery, or YAG (yttrium aluminum garnet) laser posterior capsulotomy;\n   5. Prior other intraocular surgery (e.g., pars plana vitrectomy \\[PPV\\], glaucoma surgery \\[except YAG peripheral iridotomy \\>3 months prior\\], corneal transplant, or radiotherapy).\n7. Active intraocular inflammation (grade trace or above) in the study eye before the first dose;\n8. Current vitreous hemorrhage (grade trace or above) in the study eye before the first dose;\n9. Monocular vision or non-study eye BCVA \\\u003C 24 letters before the first dose;\n10. History of any cardiovascular\u002Fcerebrovascular events within 6 months before the first dose, including but not limited to: stroke (cerebrovascular accident), myocardial infarction, unstable angina, ventricular arrhythmias, and heart failure ≥ NYHA Class II;\n11. History of major surgery within 6 months before the first dose or plan to undergo surgery during the study;\n12. History of other disease, metabolic dysfunction, abnormal physical examination finding, or clinical laboratory finding prompting reasonable suspicion of a condition that might affect interpretation of the results of the study or render the patient at high risk for treatment complications in the opinion of the investigator, including but not limited to:\n\n    1. Hepatic\u002Frenal dysfunction (ALT\u002FAST\\>2.5×ULN; Cr\u002FBUN\\>2×ULN);\n    2. Uncontrolled diabetes (HbA1c≥7.5%);\n    3. Uncontrolled hypertension (resting SBP ≥160 mmHg and\u002For DBP ≥100 mmHg);\n    4. Platelets\\\u003C100×10⁹\u002FL; or coagulation dysfunction (PT\\>3 sec above ULN; APTT \\>10 sec above ULN);\n13. Pregnant or nursing (lactating) women;\n14. Any other conditions deemed by the investigator to render the participant unsuitable for trial participation.","ALL","50 Years","80 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).\n\nIn SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.\n\nIn MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.\n\nAfter GB10 intervention, the participants will undergo tests to evaluate the PK\u002FPD characteristics of GB10 and ocular and non-ocular safety.",[27],"Neovascular Age-Related Macular Degeneration (nAMD)",[29,30,31],"nAMD","GB10","PK\u002FPD","NOT_YET_RECRUITING","2026-02-05",{"date":35,"type":36},"2026-02-12","ACTUAL",{"date":35,"type":21},{"date":39,"type":21},"2027-06-30",{"name":41,"class":42},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100611198","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-gb18-injection-in-healthy-participants-100611198","NCT07237464","To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Following Single Subcutaneous Injection in Healthy Adult Participants","Inclusion Criteria:\n\n1. Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures, and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n2. Male and female participants aged 18-55 years (inclusive), at the time of signing the ICF.\n3. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)\u002Fheight 2 (m) 2) of 18.5-26 kg\u002Fm2 (inclusive).\n4. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests.\n5. Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n2. History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb.\n3. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies.\n4. History of recurrent infections or active infections.\n5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior, or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n6. Smoking more than five cigarettes per day on average, or habitually used nicotine containing products, or unable to refrain from smoking during the trial.\n7. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.\n8. Exposure to live vaccines within 28 days of screening.\n9. Previous administration with an investigational drug within 30 days or marketed or investigational monoclonal antibodies within 3 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n10. History of drug abuse within the past 5 years or use of drugs in the 3 months prior to screening, or a positive urine drug test at screening.\n11. Screening BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.\n12. Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval \\>450 msec, or QRS interval \\>120 msec). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility.\n13. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:\n\n    * AST or ALT level ≥1.5 × ULN,\n    * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.\n14. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 3 months of Screening. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 360 mL beer, 45 mL of 40% spirit or 150 mL of wine).\n15. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.\n16. Participants who, in the judgment of the investigator, are not suitable for participation in the study.\n17. Skin scar, rash, or ulceration at the injection site (abdomen).\n18. History of vasovagal syncope or needle phobia, and inability to tolerate venous indwelling catheter blood collection.\n19. Participants who plan to donate sperm or oocytes within 6 months after administration of the investigational drug.",true,"18 Years","55 Years",{"count":55,"type":21},36,[24],"This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.\n\nA total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo.\n\nThe arms of this study include:\n\nTo evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants.\n\nTo characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants.\n\nTo characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants.\n\nTo evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.",[59,60,61],"Cancer Cachexia (CC)","Cancer Cachexia","Cancer Cachexia Syndrome",[63,64,65,66,67,68],"Cancer cachexia","GB18","healthy adult","Phase I","pharmacokinetics","pharmacodynamics","RECRUITING","2025-11-16",{"date":72,"type":36},"2025-11-19",{"date":74,"type":36},"2025-10-28",{"date":76,"type":21},"2026-04-20",{"name":41,"class":42},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100602651","phase-2-evaluating-the-efficacy-and-safety-of-gb08-injection-in-pediatric-patients-with-growth-hormone-deficiency-100602651","NCT07126288","Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency","A Phase II\u002FIII, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency","Inclusion Criteria:\n\n1\\. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following:\n\n1. Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009.\n2. Annualized height velocity (AHV) ≤ 5.0 cm\u002Fyear, calculated from measurement of 6 to 18 months before screening.\n3. GH peak ≤ 10 ng\u002Fml proved by two different GH stimulation tests within a year before screening.\n4. Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls \\\u003C 10 years old and boys \\\u003C 11 years old.\n\n2\\. Aging \\> 3 years and ≤ 10 years (girls) or ≤ 11 years (boys) based on birth date; Tanner stage I (testicular volume \\\u003C 4 ml for boys and no palpable breast tissue for girls) 3. Uniform short stature with normal intellectual development. 4. IGF-1 levels below the mean for children and adolescents of the same age and sex, at least 1 SD below (IGF-1 SDS ≤ -1.0).\n\n5\\. Body mass index (BMI) within ±2 SD of the mean BMI for children and adolescents of the same age and sex.\n\n6\\. For subjects with GHD as part of multiple pituitary hormone deficiencies, must be stable for ≥1 month, as determined by the investigator.\n\n7\\. Guardians understand and sign the Informed Consent Form (ICF). If the participant is ≥8 years old, they must also sign the ICF. For participants \\\u003C8 years old who can express consent, their consent must be recorded.\n\nExclusion Criteria:\n\n1. History of systematic growth-promoting therapy, including growth hormone and sex hormones.\n2. Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.\n3. Closed epiphyses.\n4. Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.\n5. Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma.\n6. Any clinically significant abnormalities that may affect growth or growth assessment; subjects with liver or kidney dysfunction (ALT \\> 1.5 times upper limit of normal, creatinine \\> upper limit of normal), chronic diseases (malnutrition, fasting blood glucose ≥ 126 mg\u002FdL or HbA1c ≥ 6.5%), diabetes, severe cardiac, pulmonary, hematological, or systemic infections, immunodeficiency, psychiatric disorders, or congenital malformations.\n7. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, or tuberculosis (HBV surface antigen-positive subjects must undergo HBV DNA testing; HCV antibody-positive subjects must undergo HCV RNA testing; if HBV DNA or HCV RNA \\> detection limit, they are excluded).\n8. Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.\n9. History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.\n10. History of radiation therapy or chemotherapy.\n11. Congenital intracranial hypertension.\n12. Femoral head slipped epiphysis (SCFE).\n13. Spinal scoliosis \\> 15°.\n14. Participation in any other drug clinical trial within the past 3 months (as a subject).\n15. Other factors deemed unsuitable for participation in the study by the investigator.","3 Years","11 Years",{"count":89,"type":21},268,[91,92],"PHASE2","PHASE3","This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD). It seeks to resolve the following questions:\n\n* 1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?\n* 2: Which dose (0.4 mg\u002Fkg, 0.8 mg\u002Fkg, and 1.2 mg\u002Fkg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?\n* 3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.\n\nThis is a Phase II\u002FIII, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial with two stages. Stage 1 answers questions #1 and #2 by comparing the efficacy and safety of GB08 injection and Norditropin NordiFlex intervention among PGHD at 24 weeks. It involves four groups (n=16 each): GB08 0.4 mg\u002Fkg, GB08 0.8 mg\u002Fkg, GB08 1.2 mg\u002Fkg, and Norditropin NordiFlex 0.035 mg\u002Fkg. GB08 and Norditropin NordiFlex will be administered once weekly and once daily, respectively. The primary outcome measurement is annualized height velocity (AHV) at 24 weeks. Other measurements include growth hormone levels, safety parameters, immunogenicity markers, and pharmacokinetic\u002Fpharmacodynamic profiles.\n\nThe optimal GB08 dose will be further investigated in Stage 2, which answers question #3. At this stage, PGHD patients will randomly receive either GB08 injection or Norditropin NordiFlex intervention for 52 weeks (n=102 for each). After that, the efficacy and safety of GB08 will also be detected.",[95,96,97],"Growth Hormone Deficiency in Children","Growth Hormone Deficiency (GHD)","Growth Hormone",[99,100,101,102,103],"growth hormone deficiency","annualized height velocity","growth hormone","clinical trial","GB08 injection","2025-08-17",{"date":106,"type":36},"2025-08-22",{"date":108,"type":21},"2025-08-31",{"date":110,"type":21},"2028-12-23",{"name":41,"class":42},16,""]