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NCT Number: NCT06992661

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.

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Key information

Conditions

Interstitial Lung Disease (ILD) Healthy Volunteers Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Jingya Zhao, Ph. D

CONTACT

[email protected]

86-21-64370045

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

ICD patients:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Oral RJ026 capsules

Drug

Both the oral dosage form and the inhalation solution share the identical active ingredient.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  2. 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

    Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  3. 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

    Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  4. 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

    T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  5. 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

    AUC0-24 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.

  6. AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients

    Time frame: 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.

  7. Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients

    Time frame: 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.

  8. Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients

    Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose

    Cmax: Peak BALF Concentration. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  9. T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients

    Time frame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose

    T1/2: Half-life. Lung pharmacokinetic (PK) parameters of RJ026 in ILD patients.

  10. 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

    AUC0-24 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

  11. 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

    AUC0-∞: Area Under the plasma concentration-time Curve from time zero to infinity. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.

  12. 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

    Tmax: Time to reach maximum plasma concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.

  13. 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

    Cmax: Peak Plasma Concentration. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.

  14. 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

    T1/2: Half-life. Plasma pharmacokinetic (PK) parameters of RJ026 in healthy volunteers.

  15. Incidence of adverse events and serious adverse events.

    Time frame: Through study completion, an average of 7 days

    Safety Evaluation

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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