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

ConditionsInterstitial Lung Disease (ILD)Healthy Volunteers

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age40+

SponsorRuijin Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

RJ026 inhaled powder
Drug
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
Drug
Both the oral dosage form and the inhalation solution share the identical active ingredient.

Treatment groups

84 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Experimental 1-ICDExperimental treatment 1 intervention

Group B: Experimental 2-ICDExperimental treatment 1 intervention

Group C: Experimental 3-ICDExperimental treatment 1 intervention

Group D: Active Comparator-ICDActive comparator 1 intervention

Group E: Experimental 1-Healthy volunteerExperimental treatment 1 intervention

Group F: Experimental 2-Healthy volunteerExperimental treatment 1 intervention

Group G: Experimental 3-Healthy volunteerExperimental treatment 1 intervention

Group H: Active Comparator-Healthy volunteerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

AUC0-24 hours of blood samples in ILD patients

AUC0-24 hours: Area Under the plasma concentration-time Curve from time zero to 24 hours post dose. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.

Time frame