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

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.

Timeline

Start

2025-05-15

Primary completion

2026-12-31

Completion

2026-12-31

Drugs

Indications