Interstitial Lung Disease (ILD)Phase 1NCT06992661
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
A Phase 1 study testing RJ026 inhaled powder and Oral RJ026 capsules in people with Interstitial Lung Disease (ILD) and Healthy Volunteers, run by Ruijin Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease (ILD), Healthy Volunteers
- What is being tested?
- RJ026 inhaled powder and Oral RJ026 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jingya Zhao, Ph. D, 86-21-64370045, jingya2010@126.com
About this study
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.
- Being tested
- RJ026 inhaled powder, Oral RJ026 capsules
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RJ026 inhaled powderDrug
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.
Oral RJ026 capsulesDrug
Both the oral dosage form and the inhalation solution share the identical active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1-ICD | Experimental | RJ026 inhaled powder, 4 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Experimental 2-ICD | Experimental | RJ026 inhaled powder, 8 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Experimental 3-ICD | Experimental | RJ026 inhaled powder, 12 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Active Comparator-ICD | Active comparator | RJ026 600mg, Oral Receives: Drug: Oral RJ026 capsules |
| Experimental 1-Healthy volunteer | Experimental | RJ026 inhaled powder, 4 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Experimental 2-Healthy volunteer | Experimental | RJ026 inhaled powder, 8 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Experimental 3-Healthy volunteer | Experimental | RJ026 inhaled powder, 12 mg, inhalation Receives: Drug: RJ026 inhaled powder |
| Active Comparator-Healthy volunteer | Experimental | RJ026 600mg, Oral Receives: Drug: Oral RJ026 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 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
Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 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
Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 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
T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 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
AUC0-24 hours: Area Under the BALF concentration-time Curve from time zero to 24 hours post-dose. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
AUC0-∞: Area Under the BALF concentration-time Curve from time zero to infinity. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Tmax: Time to reach maximum BALF concentration. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Cmax: Peak BALF Concentration. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
T1/2: Half-life. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.
Measured: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
AUC0-24 hours of blood samples in healthy volunteers
AUC0-24 hours: Area Under the plasma concentration-time Curve from time zero to 24 hours post-dose. Lung pharmacokinetic (PK) parameters of RJ026 in healthy volunteers
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
AUC0-∞ of blood samples in healthy volunteers
AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.
Measured: 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 healthy volunteers
Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.
Measured: 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 healthy volunteers
Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.
Measured: 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 healthy volunteers
T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
Incidence of adverse events and serious adverse events.
Safety Evaluation
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992661
- Sponsor's protocol ID
- 20250508
- Status last verified
- Feb 2026
- First submitted
- 9 May 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06992661
- Acronym / sponsor ID
- 20250508
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Experimental 1-ICD | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 4 mg, inhalation |
| Experimental 2-ICD | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 8 mg, inhalation |
| Experimental 3-ICD | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 12 mg, inhalation |
| Active Comparator-ICD | Active comparator | Drug: Oral RJ026 capsulesRJ026 600mg, Oral |
| Experimental 1-Healthy volunteer | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 4 mg, inhalation |
| Experimental 2-Healthy volunteer | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 8 mg, inhalation |
| Experimental 3-Healthy volunteer | Experimental | Drug: RJ026 inhaled powderRJ026 inhaled powder, 12 mg, inhalation |
| Active Comparator-Healthy volunteer | Experimental | Drug: Oral RJ026 capsulesRJ026 600mg, Oral |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RJ026 inhaled powderDeveloped 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 | Experimental 1-Healthy volunteer, Experimental 1-ICD, Experimental 2-Healthy volunteer, Experimental 2-ICD, Experimental 3-Healthy volunteer, Experimental 3-ICD |
| Oral RJ026 capsulesBoth the oral dosage form and the inhalation solution share the identical active ingredient. | Drug | Active Comparator-Healthy volunteer, Active Comparator-ICD |
Primary outcome
AUC0-24 hours of blood samples in ILD patients
Time frame: 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: Area Under the plasma concentration-time Curve from time zero to 24 hours post dose. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.
15 secondary outcomes
AUC0-∞ of blood samples in ILD patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
AUC0-24 hours of blood samples in healthy volunteers
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
AUC0-∞ of blood samples in healthy volunteers
Time frame: 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 healthy volunteers
Time frame: 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 healthy volunteers
Time frame: 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 healthy volunteers
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
Incidence of adverse events and serious adverse events.
Time frame: Through study completion, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RJ026 inhaled powder and Oral RJ026 capsules in people with Interstitial Lung Disease (ILD) and Healthy Volunteers, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24 hours of blood samples in ILD patients (time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.