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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 84
Treatments
Experimental: Experimental 1-ICD
RJ026 inhaled powder, 4 mg, inhalation
Experimental: Experimental 2-ICD
RJ026 inhaled powder, 8 mg, inhalation
Experimental: Experimental 3-ICD
RJ026 inhaled powder, 12 mg, inhalation
Active_comparator: Active Comparator-ICD
RJ026 600mg, Oral
Experimental: Experimental 1-Healthy volunteer
RJ026 inhaled powder, 4 mg, inhalation
Experimental: Experimental 2-Healthy volunteer
RJ026 inhaled powder, 8 mg, inhalation
Experimental: Experimental 3-Healthy volunteer
RJ026 inhaled powder, 12 mg, inhalation
Experimental: Active Comparator-Healthy volunteer
RJ026 600mg, Oral
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials