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

Recruiting now · Phase 1

Conditions studied: Interstitial Lung Disease (ILD), Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT06992661
Run by: Ruijin Hospital
People needed: 84
Starts: 2025-05-15
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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