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

NCT06992661 | Recruiting Phase 1

• 1 other identifier: 20250508
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Lung Disease (ILD); Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose

Secondary Outcomes (15)

• AUC0-∞ of blood samples in ILD patients

  Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose

• Tmax of blood samples in ILD patients

  Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose

• Cmax of blood samples in ILD patients

  Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose

• T1/2 of blood samples in ILD patients

  Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose

• AUC0-24 hours of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients

  1 hours, 6 hours, 12 hours, and 24 hours post-dose

Study Arms (8)

Experimental 1-ICD

EXPERIMENTAL

RJ026 inhaled powder, 4 mg, inhalation

Drug: RJ026 inhaled powder

Experimental 2-ICD

EXPERIMENTAL

RJ026 inhaled powder, 8 mg, inhalation

Drug: RJ026 inhaled powder

Experimental 3-ICD

EXPERIMENTAL

RJ026 inhaled powder, 12 mg, inhalation

Drug: RJ026 inhaled powder

Active Comparator-ICD

ACTIVE COMPARATOR

RJ026 600mg, Oral

Drug: Oral RJ026 capsules

Experimental 1-Healthy volunteer

EXPERIMENTAL

RJ026 inhaled powder, 4 mg, inhalation

Drug: RJ026 inhaled powder

Experimental 2-Healthy volunteer

EXPERIMENTAL

RJ026 inhaled powder, 8 mg, inhalation

Drug: RJ026 inhaled powder

Experimental 3-Healthy volunteer

EXPERIMENTAL

RJ026 inhaled powder, 12 mg, inhalation

Drug: RJ026 inhaled powder

Active Comparator-Healthy volunteer

EXPERIMENTAL

RJ026 600mg, Oral

Drug: Oral RJ026 capsules

Interventions

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.

Experimental 1-Healthy volunteer; Experimental 1-ICD; Experimental 2-Healthy volunteer; Experimental 2-ICD; Experimental 3-Healthy volunteer; Experimental 3-ICD

Oral RJ026 capsules DRUG

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

Active Comparator-Healthy volunteer; Active Comparator-ICD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)