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A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease

RecruitingPhase 1Ages 40 Years - anyAllRuijin Hospital
NCT06992661 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pe

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📋 Eligibility rules (as published)
ICD patients: Inclusion Criteria: 1. Age ≥40 years, any gender 2. Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT 3. FVC ≥40% predicted, DLCO ≥40% predicted, FEV1/FVC ≥0.7 4. Able to tolerate bronchoscopy 5. Willing to use effective contraception during study 6. Capable of proper inhaler use Exclusion Criteria: 1. Pregnancy or lactation 2. Allergy to study drug components 3. Active respiratory infection or acute cardiopulmonary disease 4. Abnormal liver function (ALT/AST/GGT \> ULN or total bilirubin \> ULN) 5. Recent smoking (within 6 months) or alcohol abuse 6. Participation in other clinical trials within 3 months 7. Blood donation ≥400mL within 3 months 8. HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive
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What it tests

  • RJ026 inhaled powder
  • Oral RJ026 capsules
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Where

1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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