Status:
RECRUITING
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
Lead Sponsor:
Ruijin Hospital
Conditions:
interstitial lung disease (ild)
healthy volunteers
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
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, d...
Eligibility Criteria
Inclusion
- Age ≥40 years, any gender
- Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT
- FVC ≥40% predicted, DLCO ≥40% predicted, FEV1/FVC ≥0.7
- Able to tolerate bronchoscopy
- Willing to use effective contraception during study
- Capable of proper inhaler use
Exclusion
- Pregnancy or lactation
- Allergy to study drug components
- Active respiratory infection or acute cardiopulmonary disease
- Abnormal liver function (ALT/AST/GGT \> ULN or total bilirubin \> ULN)
- Recent smoking (within 6 months) or alcohol abuse
- Participation in other clinical trials within 3 months
- Blood donation ≥400mL within 3 months
- HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06992661
Start Date
January 15 2026
End Date
July 1 2026
Last Update
February 6 2026
Active Locations (1)
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1
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025