Chinese OINDP developer CF Pharmtech has announced the initiation of its Phase 1 trial of its ICF004 dry powder inhaler, which the company is developing for the treatment of fibrotic lung diseases. The study record says that the Chinese SAD/MAD study is expected to enroll 73 healthy volunteers aged 18-50 .
According to the announcement, ICF004 has “demonstrated anti-fibrotic activity in certain preclinical fibrosis models and had effects on certain research parameters associated with pulmonary fibrosis.” The study record explains that “Preclinical studies suggest that ICF004 may affect signaling pathways involved in fibrosis, including pathways related to transforming growth factor beta 1 (TGF-beta 1).”
CF Pharmtech notes that ICF004 has already been evaluated in human subjects in several previous studies and that it is conducting the new Phase 1 trial for registration purposes. The company reports that two prior investigator-led studies in healthy volunteers found that the inhalation powder was generally well tolerated, with no serious adverse events observed, and that “relevant local exposure assessment results were broadly consistent with the research and development expectations of increasing local pulmonary exposure while reducing systemic exposure.”
Read the CF Pharmtech announcement
