A Study of the Pharmacokinetics and Safety of Single-dose Inhaled ICF004 in Healthy Volunteers and Patients With Interstitial Lung Disease

NCT ID: NCT06992661

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-07-01

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.

Conditions

Interstitial Lung Disease (ILD); Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental 1-ICD

ICF004 inhaled powder, 4 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Experimental 2-ICD

ICF004 inhaled powder, 8 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Experimental 3-ICD

ICF004 inhaled powder, 12 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Active Comparator-ICD

Teavigo®, 600mg, Oral

Group Type: ACTIVE_COMPARATOR

Oral Teavigo® capsules

Intervention Type: DRUG

Teavigo® is a standardized, high-purity epigallocatechin gallate (EGCG) supplement developed by DSM Nutritional Products. The oral capsules contain ≥94% pure EGCG extracted from green tea (Camellia sinensis), making them one of the most concentrated commercially available EGCG formulations.

Experimental 1-Healthy volunteer

ICF004 inhaled powder, 4 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Experimental 2-Healthy volunteer

ICF004 inhaled powder, 8 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Experimental 3-Healthy volunteer

ICF004 inhaled powder, 12 mg, inhalation

Group Type: EXPERIMENTAL

ICF004 inhaled powder

Intervention Type: DRUG

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Active Comparator-Healthy volunteer

Teavigo®, 600mg, Oral

Group Type: EXPERIMENTAL

Oral Teavigo® capsules

Intervention Type: DRUG

Teavigo® is a standardized, high-purity epigallocatechin gallate (EGCG) supplement developed by DSM Nutritional Products. The oral capsules contain ≥94% pure EGCG extracted from green tea (Camellia sinensis), making them one of the most concentrated commercially available EGCG formulations.

Interventions

ICF004 inhaled powder

ICF004 is an investigational inhaled powder formulation containing epigallocatechin gallate (EGCG), the most biologically active polyphenol component derived from green tea extract. Developed for targeted pulmonary delivery, ICF004 utilizes a proprietary RS01 dry powder inhaler device to achieve localized therapeutic effects in lung tissue while minimizing systemic exposure.

The formulation consists of micronized EGCG (≥90% purity) in precisely dosed capsules (1mg or 4mg per unit). 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 EGCG doses (European Food Safety Authority recommends <800mg/day orally).

Intervention Type: DRUG

Oral Teavigo® capsules

Teavigo® is a standardized, high-purity epigallocatechin gallate (EGCG) supplement developed by DSM Nutritional Products. The oral capsules contain ≥94% pure EGCG extracted from green tea (Camellia sinensis), making them one of the most concentrated commercially available EGCG formulations.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jieming QU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jingya Zhao, Ph. D

Role: primary

Other Identifiers

20250508

Identifier Type: -

Identifier Source: org_study_id