Zhitong Finance App News, Changfeng Pharmaceutical (02652) announced that the Phase I clinical trial of ICF004 (Chemical Class 1) (ICF004), an inhaled powder spray developed by the Group to treat interstitial lung disease (ILD), has completed the enrollment and administration of the first healthy subject. These developments indicate that ICF004 has entered the patient administration phase after being approved to conduct this phase I clinical trial.
ILD is a group of heterogeneous diseases involving the interstitial lung. Some types, including idiopathic pulmonary fibrosis (“IPF”) and fibrosis ILD with progressive pulmonary fibrosis (PPF) phenotype, may continue to progress and lead to decreased lung function, and related patients still have unmet clinical treatment needs.
ICF004 uses inhalation administration to deliver drugs directly to the lungs, increase local drug exposure in the lungs, and reduce systemic drug exposure.
Prior to the commencement of this registered phase I clinical trial, the relevant researchers conducted a researcher-initiated clinical study (IIT) called “Study on the safe tolerability and pharmacokinetics of ICF004 nebulized inhalation solution in a single dose in healthy subjects”. Preliminary results showed overall tolerability in subjects who had completed observation and within the assessed dose range; no serious adverse events had been reported as of the relevant data cut-off date.
After optimizing the dosage form, relevant researchers also carried out a “pharmacokinetics and safety study of single inhalation of ICF004 in patients with interstitial lung disease”. As of the date of this announcement, initial safety observations showed overall tolerability in subjects who had completed administration and follow-up and within the assessed dosage range. Preliminary pharmacokinetics and related local exposure assessment results are generally consistent with research expectations for improving local pulmonary exposure and reducing systemic exposure.
The enrollment and administration of the first healthy subject in this registered phase I clinical trial is a phased advance in the ICF004 clinical development process. It also helps the Group to accumulate experience in the development and clinical transformation of complex inhalation formulations, pulmonary delivery systems and related drug delivery devices.