[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Reistone Biopharma Company Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100619815","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-rss0343-tablets-in-patients-with-chronic-obstructive-pulmonary-disease-100619815",false,"NCT07349524","A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease","Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Aged 40 to 80 years, male or female.\n3. Body mass index (BMI) ≥18 kg\u002Fm².\n4. Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.\n5. Post-bronchodilator FEV₁\u002FFVC \\\u003C0.7 at the screening period; and post-bronchodilator FEV₁\u002FFVC \\\u003C0.7 with FEV₁% predicted ≥20% at baseline.\n6. Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.\n7. On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.\n8. COPD Assessment Test (CAT) score ≥10 at screening and randomization.\n9. Current or former smoking history of ≥10 pack-years at screening.\n10. Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm\u002Fova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.\n\nExclusion Criteria:\n\n1. Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.\n2. Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.\n3. Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive\u002Fexpectorant medications, infusion of blood products or immunoglobulins.\n4. Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.\n5. Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.\n6. Participation in another clinical trial involving an investigational product with active ingredients within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening.\n7. Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.\n8. Lung surgery or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.\n9. Requirement for supplemental oxygen therapy for ≥15 hours per day or mechanical ventilation; or clinically significant sleep apnea requiring the use of a continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.\n10. Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.\n11. Coexisting other respiratory or respiratory-related diseases.\n12. Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.\n13. Presence of autoimmune diseases mediated by eosinophils at screening.\n14. Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.\n15. Diagnosis of psoriasis or lichen planus; Reiter's disease\u002Fkeratoderma blennorrhagicum, keratoderma hemorrhagicum, or reactive arthritis; systemic lupus erythematosus, atopic dermatitis, chronic hand dermatitis, chronic contact dermatitis, or chronic psoriasis; chloracne, extensive verruca vulgaris, or keratotic dermatitis.\n16. Known other severe medical conditions.\n17. Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria.\n18. Suspected or known hypersensitivity to the investigational product or any of its excipients.\n19. Blood donation or blood loss ≥200 mL within 1 month prior to randomization, or ≥400 mL within 3 months prior to the first dose; or receipt of a blood transfusion within 8 weeks prior to the first dose; or difficulty with venipuncture, or physical condition unsuitable for intensive blood sampling.\n20. Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period.\n21. History of drug abuse or substance abuse within 1 year prior to screening.\n22. Any other medical or social reason deemed by the investigator to make the subject unsuitable for participation in the trial.","ALL","40 Years","80 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.",[27],"Chronic Obstructive Pulmonary Disease","RECRUITING","2026-06-03",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2026-03-10",{"date":36,"type":21},"2028-04",{"name":38,"class":39},"Reistone Biopharma Company Limited","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100634710","phase-3-a-multicenter-randomized-double-blind-placebo-controlled-phase-iii-clinical-study-to-evaluate-the-efficacy-and-safety-of-rss0393-ointment-in-adult-patients-with-plaque-psoriasis-100634710","NCT07543224","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of RSS0393 Ointment in Adult Patients With Plaque Psoriasis.","Inclusion Criteria:\n\n1. Age must be ≥18 years on the day of signing the informed consent form, male or female.\n2. Body Mass Index (BMI = weight \\[kg\\] \u002F height² \\[m²\\]) ≥18.0 kg\u002Fm² at screening.\n3. A history of plaque psoriasis for ≥6 months.\n4. Body Surface Area (BSA) involvement of psoriasis lesions between 2% and 20%, and a Psoriasis Area and Severity Index (PASI) score ≥2, and a Physician's Global Assessment (PGA) score ≥2 at both screening and baseline.\n\nExclusion Criteria:\n\n1. Presence of any of the following skin abnormalities or conditions:\n\n   The participant is diagnosed with skin diseases or conditions other than plaque psoriasis during the screening period that, in the investigator's opinion, may interfere with the evaluation of study-related endpoints.\n2. Use of any of the following medications or participation in clinical studies:\n\n1\\) Treatment with topical anti-psoriatic medications within 14 days prior to baseline, or systemic anti-psoriatic therapies or phototherapy within 28 days prior to baseline, or biologics for psoriasis within the protocol-specified washout period prior to baseline.\n\n2\\) Participation in any clinical study (including investigational vaccines) or medical device trial within 3 months prior to baseline or within 5 elimination half-lives of the prior investigational product (whichever is longer).\n\n3.Presence of any significant medical histories or underlying conditions that may affect safety.\n\n4.Any of the following laboratory abnormalities and\u002For 12-lead ECG findings at screening\u002Fbaseline:\n\n1. Hemoglobin \\\u003C100.0 g\u002FL (for males) or \\\u003C90.0 g\u002FL (for females);\n2. White blood cell count \\\u003C3.0 × 10⁹\u002FL;\n3. Neutrophil count \\\u003C1.5 × 10⁹\u002FL;\n4. Platelet count \\\u003C100 × 10⁹\u002FL;\n5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 × the upper limit of normal (ULN);\n6. Total bilirubin (TBIL) \\>1.5 × ULN;\n7. Estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (MDRD) study equation \\\u003C60 mL\u002Fmin\u002F1.73 m², or serum creatinine outside the normal range, and considered by the investigator as unsuitable for study participation;\n8. Positive test for hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, syphilis antibody, or anti-hepatitis C virus (HCV) antibody; OR a 12-lead ECG showing clinically significant abnormalities that may affect participant safety.\n\n5\\. General Conditions:\n\n1. Women who are pregnant or breastfeeding.\n2. Known hypersensitivity to the investigational product or any of its excipients.\n3. History or suspicion of alcohol abuse, drug abuse, or substance abuse, in the investigator's judgment.\n4. Administration of a live-attenuated vaccine within 12 weeks prior to randomization, intention to receive a live-attenuated vaccine during the study, or participation in a vaccine clinical trial within 12 weeks prior to randomization.\n5. Donation of approximately 500 mL of blood within 8 weeks prior to randomization, or plans to donate blood during the study period.\n6. Anticipated use of artificial or natural ultraviolet (UV) light exposure (e.g., phototherapy, tanning beds, extensive sun exposure) on the treatment areas during the study treatment period, which, in the investigator's judgment, could interfere with efficacy evaluations.","18 Years",{"count":49,"type":21},600,[51],"PHASE3","Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.",[54],"Plaque Psoriasis Subjects","NOT_YET_RECRUITING","2026-04-15",{"date":58,"type":32},"2026-04-21",{"date":60,"type":21},"2026-04",{"date":62,"type":21},"2027-12",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":16,"minAge":47,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100615196","phase-1-a-clinical-study-of-rss0343-in-healthy-subjects-100615196","NCT07289464","A Clinical Study of RSS0343 in Healthy Subjects","A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RSS0343 Following Multiple Oral Doses in Healthy Subjects, as Well as Its Effects on the QT\u002FQTc Interval","Inclusion Criteria:\n\n1. Subjects who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.\n2. Healthy individuals aged 18 to 55 years, inclusive. Males and females\n3. Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)\u002Fheight 2 (m²). BMI between 19 and 28 kg\u002Fm², inclusive.\n4. Fertile male and female subjects and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening until 6 months (for females) or 3 months (for males) after the last dose. Additionally, fertile female subjects must have a negative serum pregnancy test at screening and prior to the first dose (baseline) and must not be lactating.\n\nExclusion Criteria:\n\n1. Subjects who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco products during the trial.\n2. Subjects with frequent alcohol consumption (\\>15 g\u002Fday for females or \\>25 g\u002Fday for males \\[5g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or approximately 17 mL of low-alcohol liquor\\], on more than 2 occasions per week) within 6 months prior to screening, or were unable to abstain during the trial, or who tested positive on the alcohol breath test at baseline.\n3. Subjects with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.\n4. Subjects who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had received a blood transfusion within 8 weeks prior to dosing.\n5. Subjects with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.\n6. Subjects deemed by the investigators to be unsuitable for the trial for any other reason.\n7. Subjects with any clinically significant abnormalities, as determined by the investigator, in physical examination, vital signs, laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation), chest imaging, abdominal ultrasonography, or electrocardiogram.\n8. Subjects who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.\n9. Subjects with a known or suspected allergy to the investigational drug or its excipients, or a history of severe allergic reactions (e.g., to drugs, food, toxins).\n10. Subjects with any active autoimmune disease or immunodeficiency at screening.\n11. Subjects with any history of severe clinical disease, or any condition that, in the investigator's judgment, could compromise trial outcomes, affect drug absorption, distribution, metabolism, or excretion (pharmacokinetics), or pose an undue risk to the subject. This includes, but is not limited to, significant disorders of the circulatory, endocrine, nervous, digestive, urinary, hematological, immune, psychiatric, or metabolic systems.\n12. Subjects who had undergone any surgery within 3 months prior to screening, had not fully recovered as determined by the investigator, or planned to undergo surgery during the trial or within 1 month after its completion.",true,"55 Years",{"count":74,"type":21},48,[76],"PHASE1","This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT\u002FQTc interval.",[79],"Non-cystic Fibrosis Bronchiectasis","2026-01-13",{"date":82,"type":32},"2026-01-14",{"date":84,"type":32},"2026-01-04",{"date":86,"type":21},"2026-09",{"name":38,"class":39},""]