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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers; Interstitial Lung Disease (ILD)

Treatments: Drug: Oral RJ026 capsules; Drug: RJ026 inhaled powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06992661

20250508

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 8 patient groups

Experimental 1-ICD

Experimental group

Description:

RJ026 inhaled powder, 4 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Experimental 2-ICD

Experimental group

Description:

RJ026 inhaled powder, 8 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Experimental 3-ICD

Experimental group

Description:

RJ026 inhaled powder, 12 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Active Comparator-ICD

Active Comparator group

Description:

RJ026 600mg, Oral

Treatment:

Drug: Oral RJ026 capsules

Experimental 1-Healthy volunteer

Experimental group

Description:

RJ026 inhaled powder, 4 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Experimental 2-Healthy volunteer

Experimental group

Description:

RJ026 inhaled powder, 8 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Experimental 3-Healthy volunteer

Experimental group

Description:

RJ026 inhaled powder, 12 mg, inhalation

Treatment:

Drug: RJ026 inhaled powder

Active Comparator-Healthy volunteer

Experimental group

Description:

RJ026 600mg, Oral

Treatment:

Drug: Oral RJ026 capsules