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

"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)."

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.