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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
Sponsor: Ruijin Hospital
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, 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 Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-01-15
Completion Date
2026-07-01
Last Updated
2026-02-06
Healthy Volunteers
Yes
Interventions
RJ026 inhaled powder
Developed for targeted pulmonary delivery, RJ026 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure. Preclinical studies demonstrate that inhaled administration achieves 10-20× higher lung concentrations compared to oral dosing, with correspondingly lower plasma levels - potentially reducing the hepatotoxicity risk associated with high oral doses.
Oral RJ026 capsules
Both the oral dosage form and the inhalation solution share the identical active ingredient.
Locations (1)
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China