[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Staidson (Beijing) Biopharmaceuticals Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,67,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100589006","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-single-and-multiple-dose-of-stsp-0902-in-healthy-subjects-100589006",false,"NCT06948799","A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects","A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects","Inclusion Criteria:\n\n1. Male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² inclusive.\n2. Participants in the multiple dose phase must meet one of the following criteria: two routine semen analysis results during the screening period meet the criteria of sperm concentration of less than 15 million and\u002For percentage of progressively motility sperm of less than 32%.\n3. Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.\n4. Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of electric blankets.\n5. Participants must give informed consent to this study before the study and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and reproductive systems (such as reproductive system infectious diseases, varicocele, reproductive tract obstruction, etc., except for oligoasthenzoospermia), as judged by the investigator, may endanger the safety of the participant or affect the study results.\n2. Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic kallikrein, within 3 months prior to screening or during the trial period.\n3. Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months prior to screening.\n4. Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.\n5. Participants who have experienced a fever exceeding 38 ℃ within 1 month prior to screening\n6. Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by the investigator.\n7. Participants who are allergic to any component of the experimental drug or biological agent, or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.\n8. Participants who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen\u002Fantibody combination test (primary screening).\n9. Tattoos at the injection site or other skin conditions that interfere with observation of the skin.\n10. Participants who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.\n11. Participants with frequent alcohol consumption within 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine); or those with a positive alcohol breath test.\n12. Participants who have habitual consumption of more than 5 cups of coffee, tea or cola, etc. per day (150 ml and above per cup) in the 3 months prior to screening.\n13. Participants who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.\n14. Participants who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have history of blood transfusion within 4 weeks prior to enrollment.\n15. Participants who have taken any investigational product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.\n16. Vaccination within 1 month prior to screening or scheduled to be administered during the study period up to 2 months after completion of the study.\n17. Participants who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.\n18. Participants with a history of fear of needles and homophobia.\n19. Participants with other factors that are not suitable for participation in this study as judged by the investigator.",true,"MALE","18 Years","50 Years",{"count":21,"type":22},64,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1b, randomized, double-blind, placebo-controlled, single and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902",[28],"Oligozoospermia","RECRUITING","2026-05-21",{"date":32,"type":33},"2026-05-22","ACTUAL",{"date":35,"type":33},"2025-05-08",{"date":37,"type":22},"2026-08",{"name":39,"class":40},"Staidson (Beijing) Biopharmaceuticals Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100605871","phase-3-bdb-001-phase-iii-trial-in-anca-associated-vasculitis-100605871","NCT07168161","BDB-001 Phase III Trial in ANCA-Associated Vasculitis","A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis","Inclusion Criteria:\n\n1. 18 years old≤Age≤75 years old, male or female;\n2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；\n3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide\u002Fazathioprine or rituximab；\n4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；\n5. Estimated glomerular filtration rate ≥15 mL\u002Fminute\u002F1.73 m\\^2；\n6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；\n\nExclusion Criteria:\n\n1. Active tuberculosis infection;\n2. alveolar hemorrhage requiring pulmonary ventilation support；\n3. History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis.\n4. Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis；\n5. HBsAg positive,or HBcAb positive and HBV-DNA positive；\n6. Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first administration；\n7. Received glucocorticoid shock therapy within 4 weeks before the first administration；\n8. Received an oral daily dose of a GC of \\> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；\n9. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；\n10. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;\n11. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;\n12. Pregnant or lactating.","ALL","75 Years",{"count":52,"type":22},300,[54],"PHASE3","The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab",[57],"ANCA Associated Vasculitis (AAV)","2026-04-21",{"date":60,"type":33},"2026-04-23",{"date":62,"type":33},"2025-11-10",{"date":64,"type":22},"2028-02-29",{"name":39,"class":40},60,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":41},"100591078","phase-2-a-phase-ii-study-of-stsp-0902-ophthalmic-solution-in-patients-with-neurotrophic-keratitis-100591078","NCT06975748","A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis","Inclusion Criteria:\n\n1. Male or female patients aged between 18 to 85 years (inclusive).\n2. Diagnosed with NK in one or both eyes, with the study eye classified as Mackie Stage 2 (PED) or Stage 3 (corneal ulcer), and with a maximum corneal defect diameter ≥2 mm.\n3. Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.\n4. NK duration \\>2 weeks in the study eye, as confirmed by the investigator based on medical history.\n5. No improvement in the study eye for ≥7 days prior to randomization.\n6. Effective non-pharmacological contraception used by the subject (and partner, if applicable) throughout the trial and for 3 months after the last dose, with no plans for pregnancy or gamete donation.\n7. Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.\n\nExclusion Criteria:\n\n1. Any eye with corneal stromal ulceration involving \\>1\u002F3 of corneal thickness or at risk of corneal melting\u002Fperforation.\n2. Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK.\n3. Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial.\n4. Bilateral vision loss severely impacting daily life, as assessed by the investigator.\n5. Study eye with Schirmer I test ≤3 mm\u002F5 minutes.\n6. Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction in the study eye that may impair corneal healing or trial outcomes.\n7. Study eye with any surgery within 3 months prior to randomization (including corneal\u002Fnon-corneal surgeries affecting trial assessments, except surgeries related to NK etiology), or planned ocular surgery during the trial.\n8. Study eye with prior surgical intervention for NK (e.g., tarsorrhaphy, conjunctival flap) that may confound efficacy assessments, or amniotic membrane transplantation within 6 weeks prior to randomization.\n9. Study eye with botulinum toxin injections to the levator muscle within 3 months prior to randomization or planned during the trial.\n10. Requirement to wear contact lenses during the trial.\n11. History of inefficacy or poor response to nerve growth factor (NGF) eye drops in any eye.\n12. Use of autologous serum eye drops, deproteinized calf blood extracts, or other growth factor-containing ocular medications in the study eye(s) planned during the trial.\n13. Use of NSAIDs, or corticosteroids in the study eye within 1 week prior to randomization or planned during the trial.\n14. Use of neurotoxic drugs (e.g., antipsychotics, antiepileptics, antihistamines) or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial, excluding those who have been using it stably for at least 4 weeks before enrollment.\n15. Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound efficacy assessments or compliance, as judged by the investigator.\n16. Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests (e.g., fluorescein).\n17. History of drug abuse or alcohol dependence.\n18. Participation in another interventional trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial.\n19. Female subjects who are pregnant, breastfeeding, or test positive for serum pregnancy; or who are failure to use effective contraception for 2 weeks prior to screening, during the trial, or for 3 months post-dosing.\n20. Difficulty administering eye drops, venous blood sampling, or history of needle phobia\u002Fvasovagal syncope.\n21. Any other condition deemed unsuitable for trial participation by the investigator.","85 Years",{"count":76,"type":22},48,[78],"PHASE2","This is a Phase II, double-blind, placebo-controlled study to evaluate the safety and efficacy of STSP-0902 ophthalmic solution in patients with neurotrophic keratitis (NK). The study plans to enroll 48 patients with Mackie Stage 2 or 3 NK affecting one or both eyes. Eligible subjects will be randomized 1:1:1 into three dosing groups. Each dosing group will follow a drug-placebo allocation (12 active: 4 placebo). Treatment involves topical ocular administration for 8 weeks. Subjects who are not healed after the 8 weeks of masked treatment period will be permitted to receive standard of care during the follow-up period",[81],"Neurotrophic Keratitis",[83,84,81],"STSP-0902","Ophthalmic Solution","2026-04-01",{"date":87,"type":33},"2026-04-07",{"date":89,"type":33},"2025-06-12",{"date":91,"type":22},"2026-04",{"name":39,"class":40},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":74,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100608979","phase-3-to-evaluate-the-safety-and-efficacy-of-stsa-1002-injection-in-patients-with-acute-respiratory-distress-syndrome-100608979","NCT07208591","To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome","Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n1. 18 years old ≤ ≤ 85 years old;\n2. laboratory tests results indicate respiratory viral infection;\n3. Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;\n4. The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)\u002F)\u002F≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;\n5. PaO2\u002FFiO2≤200mmHg;\n6. The subjects (including their partners) have no plans to have children during the trial and within 3 months after the last dose, and agree to take appropriate and effective contraceptive measures (such as contraceptive pills, condoms, etc.);\n7. Volunteer to participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. ECMO before the first dose;\n2. According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;\n3. The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;\n4. Patients with stroke or acute coronary syndrome within 3 months before randomization;\n5. Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;\n6. Severe chronic respiratory failure;\n7. Known active pulmonary tuberculosis;\n8. Combined with liver insufficiency\n9. Long-term dialysis and\u002For known severe renal impairment Cytomegalovirus infection;\n10. Known HIV infection with CD4+ T-lymphocyte count \\\u003C 200 cells\u002FμL;\n11. Organ transplant patients;\n12. Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;\n13. Septic shock\n14. Absolute neutrophil count is less than 0.5×109\u002FL;\n15. Hemoglobin is less than 60g\u002FL, or the researcher judges that there is active gastrointestinal bleeding;\n16. Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;\n\n18\\. Participated in new drug clinical trials and medication within 3 months before screening; 19. Allergic or allergic to any component of the trial drug and its excipients (such as allergic to two or more drugs); 20. Other diseases or conditions that the investigator considers unsuitable for participation in this trial.",{"count":101,"type":22},406,[54],"To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome",[105],"Acute Respiratory Distress Syndrome (ARDS)","2025-12-31",{"date":108,"type":33},"2026-01-02",{"date":110,"type":33},"2025-10-31",{"date":112,"type":22},"2026-10",{"name":39,"class":40},15,""]