[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595684":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":43,"studyPopulation":11,"armGroups":44,"interventions":57,"overallOfficials":11,"centralContacts":66,"locations":76,"responsibleParty":92,"collaborators":11,"id":94,"slug":11,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":114,"whyStopped":11,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"S-INFINITY Pharmaceuticals Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)",null,"From randomisation to study completion, up to 168 days",[14,16,18,20,22,24,28],{"measure":15,"description":11,"timeFrame":12},"Time to reach maximum plasma concentration (Tmax)",{"measure":17,"description":11,"timeFrame":12},"Maximum measured concentration (Cmax) of XH-S004",{"measure":19,"description":11,"timeFrame":12},"Maximum measured concentration of XH-S004 at steady state (Cmax,ss)",{"measure":21,"description":11,"timeFrame":12},"Area Under the Plasma Concentration-time Curve (AUC) of XH-S004",{"measure":23,"description":11,"timeFrame":12},"Change From Baseline in Blood Concentration of Active Neutrophil Elastase (NE)",{"measure":25,"description":26,"timeFrame":27},"Change from baseline in pre-brondilator FEV1 after first drug administration.","FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.","At baseline, day 28, day 112 and day 140",{"measure":29,"description":26,"timeFrame":27},"Change from baseline in post-brondilator FEV1 after first drug administration",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","Parallel Assignment","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"QUADRUPLE","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",[39,40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a multicenter, double-blind, placebo-controlled, up-titration study conducted in china, aimed at evaluating the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of XH-S004 administered once daily for 140 days in COPD patients.\n\nThis study plans to enroll 81 COPD patients. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 2 groups in 2:1 ratio (XH-S004 group: 54 participants and placebo group: 27 participants). Participants in XH-S004 group will receive XH-S004 20 mg for 28 days in treatment period 1, then up-titrated to XH-S004 40 mg for 84 days in treatment period 2, finally continue with XH-S004 60 mg for 28 days in treamtment period 3. Participants in placebo group will receive matching placebo from day 1 to day 140 (140 days in total).",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Arm1: Participant Group","EXPERIMENTAL","Up-titration design: prticipants received XH-S004 20 mg once daily (QD) from day 1 to day 28 in treatment period 1, XH-S004 40 mg once daily (QD) from day 29 to day 112 in treatment period 2, and XH-S004 60 mg once daily (QD) from day 113 to day 140 in treatment period 3.\n\nPharmaceutical form: Tablets Route of administration: Oral",[50],"Other: XH-S004 20 mg, 40 mg or 60 mg",{"label":52,"type":53,"description":54,"interventionNames":55},"Participant Group","PLACEBO_COMPARATOR","Participants received the matching placebo once daily (QD) from day 1 to day 140 in treatment period 1, treatment period 2 and treatment period 3.\n\nPharmaceutical form: Tablets Route of administration: Oral",[56],"Other: Placebo",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"OTHER","XH-S004 20 mg, 40 mg or 60 mg","Administered once per day for 140 days.",[46],{"type":59,"name":64,"description":61,"armGroupLabels":65,"otherNames":11},"Placebo",[52],[67,72],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"Bin Cao","CONTACT","+86 13911318339","caobin_ben@163.com",{"name":73,"role":69,"phone":74,"phoneExt":11,"email":75},"Yeming Wang","+86 18810663558","wwyymm_love@163.c0m",[77],{"facility":78,"status":11,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"China-Japan Friendship Hospital","Beijing","Beijing Municipality","100000","China","CN",{"type":85,"coordinates":86},"Point",[87,88],116.39723,39.9075,{"lat":88,"lon":87},[91],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},{"type":93,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":103,"type":104},81,"ESTIMATED","INTERVENTIONAL",[107],"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).",[110],"Chronic Obstructive Pulmonary Disease (COPD)",[112,113],"COPD","Active neutrophil elastase","NOT_YET_RECRUITING","2025-06-16",{"date":117,"type":118},"2025-06-25","ACTUAL",{"date":120,"type":104},"2025-07-15",{"date":122,"type":104},"2026-11-13",{"name":5,"class":6},1]