Single-dose inhaled RJ026 in people with interstitial lung disease and healthy volunteers.

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

This trial will test whether a single inhaled dose of RJ026 is safe and how the body and lungs absorb and clear it in people with interstitial lung disease and in healthy volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06992661 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, parallel-group, dose-escalation Phase 1 trial gives single doses of inhaled RJ026 at 4 mg, 8 mg, or 12 mg and includes an oral RJ026 comparator arm. The study enrolls 42 patients with ILD and 42 healthy volunteers split across the inhaled and oral cohorts. Intensive pharmacokinetic sampling includes 15 timed blood draws over 24 hours and bronchoalveolar lavage at one of several post-dose time points to measure lung exposure, with safety monitoring for seven days after dosing. The trial is conducted at Ruijin Hospital, Shanghai Jiao Tong University, with standard adverse event, vital sign, and laboratory assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 or older with diagnosed or suspected ILD (including IPF or CTD-ILD) who have FVC and DLCO ≥40% predicted, FEV1/FVC ≥0.7, can tolerate bronchoscopy, and meet other safety and contraceptive requirements.

Not a fit: Patients with severe or unstable cardiopulmonary disease, active respiratory infection, abnormal liver function, recent smoking or alcohol abuse, pregnancy or breastfeeding, or certain chronic viral infections would likely not benefit or be eligible for this study.

Why it matters

Potential benefit: If successful, RJ026 inhalation could offer a targeted option that delivers drug directly to the lungs with an acceptable safety profile for people with ILD.

How similar studies have performed: Early-phase PK and safety studies of inhaled compounds are a standard step in drug development, but inhaled RJ026 itself is novel and has not yet shown clinical efficacy in ILD.

Eligibility criteria

ICD patients:

Inclusion Criteria:

1. Age ≥40 years, any gender
2. Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT
3. FVC ≥40% predicted, DLCO ≥40% predicted, FEV1/FVC ≥0.7
4. Able to tolerate bronchoscopy
5. Willing to use effective contraception during study
6. Capable of proper inhaler use

Exclusion Criteria:

1. Pregnancy or lactation
2. Allergy to study drug components
3. Active respiratory infection or acute cardiopulmonary disease
4. Abnormal liver function (ALT/AST/GGT \> ULN or total bilirubin \> ULN)
5. Recent smoking (within 6 months) or alcohol abuse
6. Participation in other clinical trials within 3 months
7. Blood donation ≥400mL within 3 months
8. HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Interstitial Lung Disease; Healthy Volunteers