Actively Recruiting
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
Led by Ruijin Hospital · Updated on 2026-02-06
84
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of a single dose of inhaled RJ026 in both healthy volunteers and patients with interstitial lung disease (ILD). This Phase 1 study uses a randomized, double-blind, dose-escalation design to compare three inhaled doses of RJ026 (4mg, 8mg, and 12mg) against an oral dose in these populations. The study aims to establish foundational pharmacokinetic data and safety profiles for inhaled RJ026, assessing drug exposure in the lungs and blood, while comparing it to oral administration.
CONDITIONS
Brief Title
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older, any gender
- Diagnosed or suspected interstitial lung disease (IPF or CTD-ILD) confirmed by HRCT or thin-section CT
- Forced vital capacity (FVC) 40% predicted or higher
- Diffusing capacity of the lungs for carbon monoxide (DLCO) 40% predicted or higher
- Forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) 0.7 or higher
- Able to tolerate bronchoscopy procedure
- Willing to use effective contraception during the study if applicable
- Able to use the inhaler device properly
You will not qualify if you...
- Pregnant or breastfeeding
- Allergy or hypersensitivity to any components of the study drug
- Active respiratory infection or acute cardiopulmonary disease
- Abnormal liver function tests (ALT, AST, GGT above upper limit of normal or total bilirubin above normal)
- Smoking within the past 6 months or history of alcohol abuse
- Participation in other clinical trials within the past 3 months
- Blood donation of 400 mL or more within the past 3 months
- Positive for hepatitis B virus DNA above 2000 IU/mL, hepatitis C virus RNA above 1000 IU/mL, or HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 1 day
Participants receive a single dose of inhaled RJ026 or oral RJ026 capsules to evaluate pharmacokinetics and safety.
1 treatment visit with multiple blood and bronchoalveolar lavage fluid sample collections over 24 hours post-dose
Duration - Approximately 7 days
Participants are monitored for safety and adverse events after dosing.
Approximately 1 to 2 follow-up visits for safety assessments
Trial Site Locations
Total: 1 location
1
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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