[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592379":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":46,"centralContacts":46,"locations":51,"responsibleParty":72,"collaborators":46,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":46,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":46,"enrollmentInfo":85,"targetDuration":46,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":46,"overallStatus":54,"whyStopped":46,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14,18,22,28,31,34,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental 1-ICD","EXPERIMENTAL","RJ026 inhaled powder, 4 mg, inhalation",[13],"Drug: RJ026 inhaled powder",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental 2-ICD","RJ026 inhaled powder, 8 mg, inhalation",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Experimental 3-ICD","RJ026 inhaled powder, 12 mg, inhalation",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Active Comparator-ICD","ACTIVE_COMPARATOR","RJ026 600mg, Oral",[27],"Drug: Oral RJ026 capsules",{"label":29,"type":10,"description":11,"interventionNames":30},"Experimental 1-Healthy volunteer",[13],{"label":32,"type":10,"description":16,"interventionNames":33},"Experimental 2-Healthy volunteer",[13],{"label":35,"type":10,"description":20,"interventionNames":36},"Experimental 3-Healthy volunteer",[13],{"label":38,"type":10,"description":25,"interventionNames":39},"Active Comparator-Healthy volunteer",[27],[41,47],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","RJ026 inhaled powder","Developed for targeted pulmonary delivery, RJ026 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.\n\nPreclinical studies demonstrate that inhaled administration achieves 10-20× higher lung concentrations compared to oral dosing, with correspondingly lower plasma levels - potentially reducing the hepatotoxicity risk associated with high oral doses.",[29,9,32,15,35,19],null,{"type":42,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"Oral RJ026 capsules","Both the oral dosage form and the inhalation solution share the identical active ingredient.",[38,23],[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":61,"coordinates":62},"Point",[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67],{"name":68,"role":69,"phone":70,"phoneExt":46,"email":71},"Jingya Zhao, Ph. D","CONTACT","86-21-64370045","jingya2010@126.com",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Jieming QU","Professor","100592379","phase-1-a-study-of-the-pharmacokinetics-and-safety-of-single-dose-inhaled-rj026-in-healthy-volunteers-and-patients-with-interstitial-lung-disease-100592379",false,"NCT06992661","A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease","ICD patients:\n\nInclusion Criteria:\n\n1. Age ≥40 years, any gender\n2. Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT\n3. FVC ≥40% predicted, DLCO ≥40% predicted, FEV1\u002FFVC ≥0.7\n4. Able to tolerate bronchoscopy\n5. Willing to use effective contraception during study\n6. Capable of proper inhaler use\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Allergy to study drug components\n3. Active respiratory infection or acute cardiopulmonary disease\n4. Abnormal liver function (ALT\u002FAST\u002FGGT \\> ULN or total bilirubin \\> ULN)\n5. Recent smoking (within 6 months) or alcohol abuse\n6. Participation in other clinical trials within 3 months\n7. Blood donation ≥400mL within 3 months\n8. HBV DNA ≥2000 IU\u002FmL or HCV RNA ≥1000 IU\u002FmL or HIV positive",true,"ALL","40 Years",{"count":86,"type":87},84,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","This Phase 1 clinical trial investigates the pharmacokinetics and safety profile of single-dose inhaled RJ026 in healthy volunteers and patients with interstitial lung disease (ILD). The randomized, double-blind, dose-escalation study employs a parallel-group design with three inhaled dose cohorts (4mg, 8mg, and 12mg) and one oral comparator arm, enrolling a total of 42 patients (12 per inhaled group, 6 in oral group) and 42 healthy volunteers (12 per inhaled group, 6 in oral group). The trial features comprehensive pharmacokinetic sampling through 15 timed blood collections over 24 hours and bronchoalveolar lavage at specified intervals (1h, 6h, 12h, or 24h post-dose) to characterize both systemic and pulmonary drug exposure. The study incorporates rigorous safety monitoring including adverse event tracking, vital sign measurements, and laboratory assessments over a 7-day observation period following drug administration. Conducted at Shanghai Jiao Tong University's Ruijin Hospital over a 12-month period (July 2025-July 2026), this investigation aims to establish the foundational pharmacokinetic parameters and safety profile of RJ026 delivery in ILD patients while comparing pulmonary bioavailability against conventional oral administration.",[93,94],"Interstitial Lung Disease (ILD)","Healthy Volunteers","2026-02-03",{"date":97,"type":98},"2026-02-06","ACTUAL",{"date":100,"type":87},"2026-01-15",{"date":102,"type":87},"2026-07-01",{"name":5,"class":6},1]