Phase 1 Study of Single-Dose Inhaled RJ026 for Pharmacokinetics and Safety in Healthy Volunteers and Patients with Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating the pharmacokinetics and safety of single-dose inhaled RJ026 in both healthy volunteers and patients with interstitial lung disease ILD. This Phase 1, randomized, double-blind, dose-escalation study compares three inhaled doses of RJ026 4 mg, 8 mg, and 12 mg with an oral RJ026 dose. Conducted at Ruijin Hospital from May 2025 to December 2026, the trial aims to establish how the drug behaves in the body and its safety profile in ILD patients while assessing lung delivery compared to oral administration. Participants are assigned to one of four groups three inhaled RJ026 doses administered using a dry powder inhaler device, or an oral RJ026 capsule. Each group includes both ILD patients and healthy volunteers. Blood samples are collected at multiple times over 24 hours, and bronchoalveolar lavage fluid is obtained at specific intervals to measure drug exposure in the lungs and bloodstream. Safety monitoring includes tracking adverse events, vital signs, and laboratory tests during a 7-day observation period after dosing. During the study, participants undergo 15 timed blood collections within a day and bronchoscopy procedures to collect lung fluid samples at 1, 6, 12, or 24 hours post-dose. Researchers measure drug concentration over time, peak levels, and half-life in both blood and lung samples. Safety is closely observed through adverse event reporting and clinical assessments. The total study duration per participant encompasses dosing and a week of safety follow-up to understand the drugs effects and tolerability.

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