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

A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease (NCT06992661) is a Phase 1 interventional studying Interstitial Lung Disease (ILD) and Healthy Volunteers, sponsored by Ruijin Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Interstitial Lung Disease (ILD), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 84 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Interstitial Lung Disease (ILD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

ICD patients: Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

RJ026 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.

DRUG

Oral RJ026 capsules

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06992661), the sponsor (Ruijin Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06992661 clinical trial studying?

Who can participate in NCT06992661?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06992661?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06992661. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06992661. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.