A Phase 1 interventional study of RJ026 inhaled powder and Oral RJ026 capsules in Interstitial Lung Disease (ILD) and Healthy Volunteers, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Ruijin Hospital · Phase 1, Interventional, and Treatment
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.
646 studies on the registry are indexed under Lung Diseases, Interstitial; 237 are open to participants now.
This study's planned enrollment of 84 is above the median of 54 across 355 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 360 are open to participants now.
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ICD patients:
Inclusion Criteria:
Exclusion Criteria:
RJ026 inhaled powder, 4 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 inhaled powder, 8 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 inhaled powder, 12 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 600mg, Oral
Drug: Oral RJ026 capsules
RJ026 inhaled powder, 4 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 inhaled powder, 8 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 inhaled powder, 12 mg, inhalation
Drug: RJ026 inhaled powder
RJ026 600mg, Oral
Drug: Oral RJ026 capsules
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.
Both the oral dosage form and the inhalation solution share the identical active ingredient.
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.
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 ILD patients
AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 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
Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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
Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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
T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 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
Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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
Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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
T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 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.
Safety Evaluation
Time frame: Through study completion, an average of 7 days
Plan to share: No
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