[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"S-INFINITY Pharmaceuticals Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,70],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100595684","phase-1-the-phase-ib-clinical-trial-of-the-xh-s004-tablet-in-patients-with-chronic-obstructive-pulmonary-disease-copd-to-evaluate-its-safety-tolerability-pharmacokinetic-characteristics-and-pharmacodynamic-characteristics-after-multiple-administrations-100595684",false,"NCT07035652","The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations","Inclusion Criteria:\n\n1. Sign the informed consent form (ICF);\n2. Male or Female participants ages 40-80 (inclusive);\n3. BMI ≥ 18.5 kg\u002Fm2 and ≤ 26 kg\u002Fm2, with male weight ≥50 kg and female weight ≥45 kg (inclusive);\n4. Patients diagnosed with COPD according to 2024 GOLD consensus had a medical record or relevant documentation proving a history of COPD for ≥12 months at screening visit;\n5. Current or former smokers with a smoking history of ≥10 pack-years;\n6. Post-bronchodilator FEV1\u002F forced vital capacity \\[FVC\\] ratio \\\u003C0.70 and post-bronchodilator FEV1 % predicted \\>30% and ≤70%.\n7. Sputum volume≥10ml\u002Fday at screening visit;\n8. with a documented history: 1) Moderate-to-severe COPD patients with a stable SOC therapy prior to signing ICF, including LABA, LAMA, LABA\u002FLAMA, LABA\u002FLAMA\u002FICS (evaluated by investigator to confirm the treatment regimen complies with clinical practice); Continuous use with a stable dosage for ≥1 month prior to randomization; Medication compliance between 80% and 120% from signing ICF to randomization; 2) Acute exacerbation history of ≥2 moderate or ≥1 severe requiring hospitalization within 12 months prior to screening.\n9. Medical Research Council (MRC) Dyspnea Scale grade ≥2.\n10. COPD Assessment Test (CAT)≥10\n\nExclusion Criteria:\n\n1. Have a primary diagnosis of asthma as determined by the investigator;\n2. During screening period, WBC\\\u003Cthe lower limit of normal range, or absolute neutrophil count\\\u003Cthe lower limit of normal range;\n3. During screening period, blood eosinophils ≥300 cells\u002Fmicroliter;\n4. Pregnant and lactating females","ALL","40 Years","80 Years",{"count":19,"type":20},81,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC).",[26],"Chronic Obstructive Pulmonary Disease (COPD)",[28,29],"COPD","Active neutrophil elastase","NOT_YET_RECRUITING","2025-06-16",{"date":33,"type":34},"2025-06-25","ACTUAL",{"date":36,"type":20},"2025-07-15",{"date":38,"type":20},"2026-11-13",{"name":40,"class":41},"S-INFINITY Pharmaceuticals Co., Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"100591305","phase-2-a-phase-ii-study-evaluating-the-efficacy-and-safety-of-xh-s003-capsules-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-100591305","NCT06978699","A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Multicenter, Randomized, Single-blind Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","XH-S003-II-101","Inclusion Criteria:\n\n* Male or female with aged ≥18 years old;\n* Weight ≥40 kg and BMI≥18 kg\u002Fm2 ;\n* Diagnosed with PNH: with red blood cell or granulocyte clone levels \\>10% detected by flow cytopy within 6 months prior to screening or during screening;\n* Patients who have not previously received any complement inhibitor therayp;\n* LDH \\> 1.5×ULN detected two times during the screening period (interval of 2 to 8 weeks);\n* Hb meets one of the following conditions: (1) Hb \\\u003C100 g\u002FL at the first screening visit, and subjects receive RBC transfusion because of PNH-related anemia during the screening period; (2) The average Hb of two tests during the screening period \\\u003C100 g\u002FL (interval of 2\\~8 weeks);\n* Vaccination against Neisseria meningitidis and Streptococcus pneumoniae before the first administration. If the subject has not been vaccinated previously or requires booster vaccination (according to local vaccination policies), vaccination must be administered at least 2 weeks before the first administration. If the first administration must begin less than 2 weeks after vaccination, preventive antibiotic treatment must begin at least 2 weeks after vaccination;\n\nExclusion Criteria:\n\n* Subjects with laboratory evidence of bone marrow failure during the screening period (reticulocyte count \\\u003C100×109\u002FL, platelet count \\\u003C30×109\u002FL, or neutrophil count \\\u003C0.5×109\u002FL);\n* Subjects receiving other therapies prior to screening who have not achieved the following treatment durations:\n\n  • Erythropoietin or immunosuppressants for at least 8 weeks; • Systemic corticosteroids for at least 4 weeks; • Iron supplements, vitamin B12, or folic acid for at least 4 weeks; • Anticoagulants: Vitamin K antagonists for at least 4 weeks with stable international normalized ratio (INR) (as determined by the investigator), low molecular weight heparin for at least 4 weeks; • Hypoxic-inducing factor prolyl hydroxylase inhibitors (HIF-PHI) for at least 8 weeks; • Androgens for at least 4 weeks;\n* A history of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation;\n* Alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), or alkaline phosphatase (ALP) \\>3×ULN at screening; - Positive HIV antibody, active syphilis infection, positive HBsAg, active HCV infection, or active tuberculosis infection at screening;\n* Known or suspected immunodeficiency diseases or hereditary complement deficiency at screening;\n* A history of Neisseria meningitidis infection;\n* Subjects with chronic active or recurrent infections within 1 year prior to screening;\n* Subjects with systemic active bacterial, viral (including COVID-19), or fungal infections within 2 weeks prior to the first administration; subjects with body temperature \\>38°C within 7 days prior to the first administration;","18 Years",{"count":53,"type":20},24,[55],"PHASE2","This is a multicenter, randomized, single-blind Phase II trial to evaluate the efficacy and safety of XH-S003 capsules in PNH patients. About 24 PNH patients will be enrolled and randomized to three dose levels and take XH-S003 capsules orally",[58],"PNH - Paroxysmal Nocturnal Hemoglobinuria",[60],"Paroxysmal Nocturnal Hemoglobinuria","RECRUITING","2025-05-16",{"date":64,"type":34},"2025-05-18",{"date":66,"type":34},"2025-04-30",{"date":68,"type":20},"2026-10-30",{"name":40,"class":41},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":42},"100591489","phase-2-a-multicenter-randomized-double-blind-placebo-controlled-parallel-group-phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-xh-s004-tablets-in-patients-with-non-cystic-fibrosis-bronchiectasis-100591489","NCT06981091","A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of XH-S004 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis","Inclusion Criteria:\n\n1. Understand the procedures and methods of this trial and sign a written informed consent form;\n2. Male or female paticipants aged 18-85 years (inclusive) ;\n3. Chest HRCT shows bronchiectasis affecting one or more lobes, and the condition is clinically diagnosed as non-cystic fibrosis bronchiectasis (clinical manifestations include chronic cough, significant productive cough, and\u002For intermittent hemoptysis, with or without varying degrees of polypnoea and other symptoms);\n4. Based on medical history and the determination of the investigator , participants have at least 2 documented pulmonary exacerbations in the past 12 months before Screening;\n5. Are current sputum producers with a history of chronic expectoration and able to provide a spontaneous sputum sample at screening visit (as described by the patient) ;\n6. The body mass index (BMI) is ≥18 kg\u002Fm2 at screening;\n7. Participants must ensure and agree that from 28 days prior to signing the informed consent form to 28 days after the final administration, women of childbearing potential, male participants, and their partners will use effective contraception methods other than oral drugs (e.g., condoms or intra-uterine contraceptive devices) and will not donate sperm or eggs during this period\n\nExclusion Criteria:\n\n1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma\n2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency\n3. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis\n4. Have any acute infections, (including respiratory infections)\n5. Patients who have previously received therapy with DPP1 inhibitors of the same class","85 Years",{"count":78,"type":20},231,[55],"The purpose of this study is to find out if XH-S004 can reduce pulmanary exacerbation over a 24-week treatment duration in participants with non-cystic fibrosis bronchiectasis.",[82],"Non-Cystic Fibrosis Bronchiectasis",[84,29,85],"Bronchiectasis","Fibrosis","2025-05-12",{"date":88,"type":34},"2025-05-20",{"date":62,"type":20},{"date":91,"type":20},"2027-04-28",{"name":40,"class":41},""]