CF PHARMTECH (02652): ICF004 Completes Dosing of First Healthy Volunteer in Phase I Clinical Trial

CF PHARMTECH (02652) announced that the Phase I clinical trial of ICF004 (chemical drug Class 1), an inhaled powder aerosol developed by the Group for the treatment of interstitial lung disease (ILD), has completed enrollment and dosing of the first healthy volunteer. This progress marks that ICF004 has entered the subject dosing stage after being approved to conduct this Phase I clinical trial. ILD is a group of heterogeneous diseases involving the pulmonary interstitium. Some types, including idiopathic pulmonary fibrosis ("IPF") and fibrotic ILD with a progressive pulmonary fibrosis (PPF) phenotype, may continue to progress and lead to decline in lung function, and there remains an unmet clinical treatment need for affected patients. ICF004 is administered via inhalation, aiming to deliver the drug directly to the lungs, increase local drug exposure in the lungs, and reduce systemic drug exposure. Before the launch of this registered Phase I clinical trial, relevant investigators had conducted an investigator-initiated clinical study (IIT) titled "Safety and Tolerability, Pharmacokinetic Study of a Single Administration of ICF004 Nebulized Inhalation Solution in Healthy Volunteers." Preliminary results showed that, among subjects who had completed observation and within the dose range evaluated, the subjects were generally tolerant; as of the relevant data cutoff date, no serious adverse events were reported. After formulation optimization, relevant investigators also conducted a "Pharmacokinetic and Safety Study of a Single Inhalation of ICF004 in Patients with Interstitial Lung Disease." As of the date of this announcement, among subjects who had completed dosing and follow-up and within the dose range evaluated, preliminary safety observations showed overall tolerability. Preliminary pharmacokinetic and related local exposure assessment results were basically consistent with the development expectations of increasing local lung exposure and reducing systemic exposure. The completion of enrollment and dosing of the first healthy volunteer in this registered Phase I clinical trial is a milestone progress in the clinical development process of ICF004, and will also help the Group accumulate research and development and clinical translation experience in complex inhaled formulations, pulmonary delivery systems, and related administration devices.