Safety, Tolerability, and Pharmacokinetics of CG2001 in Chinese Adult Male Subjects With Androgenetic Alopecia: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multi-Dose, Phase 1 Clinical Study

This phase I clinical study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free topical foam combining minoxidil (5%) and finasteride (0.025%–0.1%), in 44 Chinese males with androgenetic alopecia. The study found that CG2001 was safe and well-tolerated, with no serious adverse events reported. Systemic exposure to finasteride was significantly lower than with oral administration, reducing potential systemic sexual side effects. Both minoxidil and finasteride reached steady state after 7 days of use. The alcohol-free formulation and reduced systemic exposure make CG2001 a promising alternative for treating androgenetic alopecia, warranting further clinical development.