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
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 ILD (IPF or CTD-ILD) based on HRCT or thin-section CT
- Forced vital capacity (FVC) 40% or more of predicted
- Diffusing capacity of the lung for carbon monoxide (DLCO) 40% or more of predicted
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of 0.7 or higher
- Able to tolerate bronchoscopy procedure
- Willing to use effective contraception during the study
- Capable of proper inhaler use
You will not qualify if you...
- Pregnancy or lactation
- Allergy to components of the study drug
- Active respiratory infection or acute cardiopulmonary disease
- Abnormal liver function tests (ALT, AST, GGT above normal limit or total bilirubin above normal limit)
- Recent smoking within 6 months or alcohol abuse
- Participation in other clinical trials within the past 3 months
- Blood donation of 400 mL or more within 3 months
- Positive for HBV DNA above 2000 IU/mL, HCV RNA above 1000 IU/mL, or HIV
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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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