The Journal of dermatological treatment · 2026
Safety, tolerability, and pharmacokinetics of CG2001 in Chinese adult male subjects with androgenetic alopecia: a randomized, double-blind, placebo-controlled, single- and multi-doses, phase 1 clinical study.
СтатьяРандомизированное исследованиеКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Li Yanting, Yu Baohui, Niu Suping, Ding Ziyan, Gu Qun, Zhang Hui, Ding Rui, Zhou Cheng, Men Fang, Liu Yian, Zhao Wenyan, Chen Liming, Li Shuang, Wang Qian, Xiao Meng, Huang Fan, Hu Binyi, Zhang Jiaojiao, Zhang Jianzhong, Fang Yi
Аннотация
OBJECTIVES: Compared with placebo, this phase I study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free minoxidil-finasteride combination topical foam, in Chinese males with androgenetic alopecia (AGA).
METHODS: In this randomized, double-blind, placebo-controlled trial, 44 subjects received single and multiple doses across five cohorts with varying finasteride concentrations (0.025%-0.1%) and frequencies. Safety, tolerability, and pharmacokinetics were evaluated. The concentrations of minoxidil-finasteride were both measured.
RESULTS: The result shows that CG2001 was safe and well-tolerated, with no serious adverse events. Systemic minoxidil exposure was consistent across most dosages, while finasteride exposure increased dose- and frequency-dependently, though it remained markedly lower than that reported with oral administration. Steady state was achieved for both drugs after 7 days.
CONCULSIONS: The favorable safety profile and reduced systemic finasteride exposure position CG2001 as a promising alternative, supporting further clinical development in a phase IIa trial, and provide a pharmacokinetic foundation for subsequent efficacy trials in patients with AGA.
METHODS: In this randomized, double-blind, placebo-controlled trial, 44 subjects received single and multiple doses across five cohorts with varying finasteride concentrations (0.025%-0.1%) and frequencies. Safety, tolerability, and pharmacokinetics were evaluated. The concentrations of minoxidil-finasteride were both measured.
RESULTS: The result shows that CG2001 was safe and well-tolerated, with no serious adverse events. Systemic minoxidil exposure was consistent across most dosages, while finasteride exposure increased dose- and frequency-dependently, though it remained markedly lower than that reported with oral administration. Steady state was achieved for both drugs after 7 days.
CONCULSIONS: The favorable safety profile and reduced systemic finasteride exposure position CG2001 as a promising alternative, supporting further clinical development in a phase IIa trial, and provide a pharmacokinetic foundation for subsequent efficacy trials in patients with AGA.