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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1-ICD | Experimental | RJ026 inhaled powder, 4 mg, inhalation |
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| Experimental 2-ICD | Experimental | RJ026 inhaled powder, 8 mg, inhalation |
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| Experimental 3-ICD | Experimental | RJ026 inhaled powder, 12 mg, inhalation |
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| Active Comparator-ICD | Active Comparator | RJ026 600mg, Oral |
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| Experimental 1-Healthy volunteer | Experimental | RJ026 inhaled powder, 4 mg, inhalation |
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| Experimental 2-Healthy volunteer | Experimental | RJ026 inhaled powder, 8 mg, inhalation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RJ026 inhaled powder | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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ICD patients:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Experimental 3-Healthy volunteer | Experimental | RJ026 inhaled powder, 12 mg, inhalation |
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| Active Comparator-Healthy volunteer | Experimental | RJ026 600mg, Oral |
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| Oral RJ026 capsules | Drug | Both the oral dosage form and the inhalation solution share the identical active ingredient. |
|
Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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 of blood samples in ILD patients | Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 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 of blood samples in ILD patients | T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 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 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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 | Through study completion, an average of 7 days |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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