Clinical trial NCT06992661: A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease
Official title: A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Interstitial Lung Disease (ILD)
Healthy Volunteers
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1 clinical trial investigates the pharmacokinetics and safety profile of single-dose inhaled ICF004, an epigallocatechin gallate (EGCG) powder formulation, 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 (600mg Teavigo®), 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 inhaled EGCG delivery in ILD patients while comparing pulmonary bioavailability against conventional oral administration.


Eligibility 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. Able to abstain from coffee/tea products 48h before to 48h after dosing
7. 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

Primary outcomes:
measure: AUC0-24 hours of blood samples in ILD patients
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
Secondary outcomes:
measure: AUC0-∞ of blood samples in ILD patients
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: Tmax of blood samples in ILD patients
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: Cmax of blood samples in ILD patients
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: T1/2 of blood samples in ILD patients
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: AUC0-24 hours of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
timeFrame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
measure: AUC0-∞ of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
timeFrame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
measure: Tmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
timeFrame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
measure: Cmax of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
timeFrame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
measure: T1/2 of BALF (Bronchoalveolar Lavage Fluid) samples in ILD patients
timeFrame: 1 hours, 6 hours, 12 hours, and 24 hours post-dose
measure: AUC0-24 hours of blood samples in healthy volunteers
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: AUC0-∞ of blood samples in healthy volunteers
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: Tmax of blood samples in healthy volunteers
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: Cmax of blood samples in healthy volunteers
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: T1/2 of blood samples in healthy volunteers
timeFrame: Baseline, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose
measure: Incidence of adverse events and serious adverse events.
timeFrame: Through study completion, an average of 7 days
Other outcomes:
Locations:
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