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

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 Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Interstitial Lung Disease (ILD)
• Intervention / Treatment: Drug: RJ026 inhaled powder; Drug: Oral RJ026 capsules

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Jingya Zhao, Ph. D; Phone Number: 86-21-64370045; Email: jingya2010@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1-ICD; RJ026 inhaled powder, 4 mg, inhalation	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.
Experimental: Experimental 2-ICD; RJ026 inhaled powder, 8 mg, inhalation	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.
Experimental: Experimental 3-ICD; RJ026 inhaled powder, 12 mg, inhalation	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.
Active Comparator: Active Comparator-ICD; RJ026 600mg, Oral	Drug: Oral RJ026 capsules; Both the oral dosage form and the inhalation solution share the identical active ingredient.
Experimental: Experimental 1-Healthy volunteer; RJ026 inhaled powder, 4 mg, inhalation	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.
Experimental: Experimental 2-Healthy volunteer; RJ026 inhaled powder, 8 mg, inhalation	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.
Experimental: Experimental 3-Healthy volunteer; RJ026 inhaled powder, 12 mg, inhalation	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.
Experimental: Active Comparator-Healthy volunteer; RJ026 600mg, Oral	Drug: Oral RJ026 capsules; Both the oral dosage form and the inhalation solution share the identical active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and serious adverse events.	Safety Evaluation	Through study completion, an average of 7 days
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	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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; epigallocatechin gallate
• Other Study ID Numbers: 20250508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No