Single-dose inhaled RJ026 in people with interstitial lung disease and healthy volunteers.
Official title: A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
Run by Ruijin Hospital · NCT06992661 · Data updated 2026-11-12
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 |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT06992661 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.