RecruitingPhase 1NCT06992661

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

Sponsor

Ruijin Hospital

Enrollment

84 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Interstitial Lung Disease (ILD)

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

Min Age: 40 Years

Inclusion Criteria7

ICD patients:
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

Exclusion Criteria8

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)
Recent smoking (within 6 months) or alcohol abuse
Participation in other clinical trials within 3 months
Blood donation ≥400mL within 3 months
HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive

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Interventions

DRUGRJ026 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.

DRUGOral RJ026 capsules

Both the oral dosage form and the inhalation solution share the identical active ingredient.