Healthy Volunteers, Interstitial Lung Disease (ILD)
Conditions
Brief 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). 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.
Interventions
DRUGRJ026 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.
DRUGOral RJ026 capsules
Both the oral dosage form and the inhalation solution share the identical active ingredient.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24 hours of blood samples in ILD patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ of blood samples in ILD patients | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| Tmax of blood samples in ILD patients | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| Cmax of blood samples in ILD patients | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| T1/2 of blood samples in ILD patients | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| AUC0-24 hours of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients | 1 hours, 6 hours, 12 hours, and 24 hours post-dose | 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. |
| AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients | 1 hours, 6 hours, 12 hours, and 24 hours post-dose | AUC0-∞: Area Under the BALF concentration-time Curve from time zero to infinity. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients | 1 hours, 6 hours, 12 hours, and 24 hours post-dose | Tmax: Time to reach maximum BALF concentration. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients | 1 hours, 6 hours, 12 hours, and 24 hours post-dose | Cmax: Peak BALF Concentration. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients | 1 hours, 6 hours, 12 hours, and 24 hours post-dose | T1/2: Half-life. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients. |
| AUC0-24 hours of blood samples in healthy volunteers | 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. Lung pharmacokinetic (PK) parameters of RJ026 in healthy volunteers |
| AUC0-∞ of blood samples in healthy volunteers | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers. |
| Tmax of blood samples in healthy volunteers | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers. |
| Cmax of blood samples in healthy volunteers | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers. |
| T1/2 of blood samples in healthy volunteers | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose | T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers. |
| Incidence of adverse events and serious adverse events. | Through study completion, an average of 7 days | Safety Evaluation |
Countries
China
Outcome results
None listed