[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595684":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"S-INFINITY Pharmaceuticals Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Other: XH-S004 20 mg, 40 mg or 60 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","XH-S004 20 mg, 40 mg or 60 mg","Administered once per day for 140 days.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Bin Cao","CONTACT","+86 13911318339","caobin_ben@163.com",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Yeming Wang","+86 18810663558","wwyymm_love@163.c0m",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"China-Japan Friendship Hospital","Beijing","Beijing Municipality","100000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":68,"type":69},81,"ESTIMATED","INTERVENTIONAL",[72],"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).",[75],"Chronic Obstructive Pulmonary Disease (COPD)",[77,78],"COPD","Active neutrophil elastase","NOT_YET_RECRUITING","2025-06-16",{"date":82,"type":83},"2025-06-25","ACTUAL",{"date":85,"type":69},"2025-07-15",{"date":87,"type":69},"2026-11-13",{"name":5,"class":6},1]