A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- AUC0-24 hours of blood samples in ILD patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Comparator-ICD
RJ026 600mg, Oral
干预措施: Oral RJ026 capsules (Drug)
Experimental 1-ICD
RJ026 inhaled powder, 4 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Experimental 2-ICD
RJ026 inhaled powder, 8 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Experimental 3-ICD
RJ026 inhaled powder, 12 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Experimental 1-Healthy volunteer
RJ026 inhaled powder, 4 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Experimental 2-Healthy volunteer
RJ026 inhaled powder, 8 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Experimental 3-Healthy volunteer
RJ026 inhaled powder, 12 mg, inhalation
干预措施: RJ026 inhaled powder (Drug)
Active Comparator-Healthy volunteer
RJ026 600mg, Oral
干预措施: Oral RJ026 capsules (Drug)
结局指标
主要结局
AUC0-24 hours of blood samples in ILD patients
时间窗: 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.
次要结局
- Incidence of adverse events and serious adverse events.(Through study completion, an average of 7 days)
- AUC0-∞ of blood samples 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(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(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(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(1 hours, 6 hours, 12 hours, and 24 hours post-dose)
- AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients(1 hours, 6 hours, 12 hours, and 24 hours post-dose)
- Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients(1 hours, 6 hours, 12 hours, and 24 hours post-dose)
- Cmax of BALF (Bronchoalveolar Lavage Fluid) samples 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(1 hours, 6 hours, 12 hours, and 24 hours post-dose)
- AUC0-24 hours of blood samples 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(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(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(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(Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose)