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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат Oral RJ026 capsules
  Both the oral dosage form and the inhalation solution share the identical active ingredient.

Первичные конечные точки

• AUC0-24 hours of blood samples in ILD patients [Срок оценки: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose]

Вторичные конечные точки (12)

• AUC0-∞ of blood samples in ILD patients [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 1 hours, 6 hours, 12 hours, and 24 hours post-dose]
• AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients [Срок оценки: 1 hours, 6 hours, 12 hours, and 24 hours post-dose]
• Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients [Срок оценки: 1 hours, 6 hours, 12 hours, and 24 hours post-dose]
• Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients [Срок оценки: 1 hours, 6 hours, 12 hours, and 24 hours post-dose]
• T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients [Срок оценки: 1 hours, 6 hours, 12 hours, and 24 hours post-dose]
• AUC0-24 hours of blood samples in healthy volunteers [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose]

Критерии участия

ICD patients:

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06992661 · 20250508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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