A phase I study to investigate the pharmacokinetics, safety and tolerability of topical applied 0.25% solution of SM04554 in male subjects with androgenetic alopecia.

Samumed Pacific Pty Ltd0 个研究点目标入组 25 人开始时间: 2015年9月18日最近更新: 2020年1月13日

适应症

试验速览

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•Males with clinical diagnosis of AGA with Norwood classification score of 5, 5A, 5V or 6
•Wiling to maintain hairstyle, use indicated shampoo & conditioner and not use semi-permanent hair products
•Willing to inform female partners to avoid direct contact as potential effects to a foetus is unknown
•Able to understand and willing to sign informed consent form

•Clinical diagnosis alopecia areata or other non-AGA forms of alopecia
•Scalp hair loss on treatment area due to disease, injury or medical therapy
•Current skin disease on treatment area or hands
•History of surgical correction for hair loss on scalp and or hair transplant
•Use of any products or devices clinically proven to promote hair loss within 24 weeks prior to Screening visit
•Use of anti-androgenic therapies within 12 weeks prior to Screening visit
•Previous exposure to SM04554
•Use of semi-permanent hair products with 30 days prior to screening
•Use medicated shampoo&conditioner or OTC hair treatments of dandruff or promotion of hair growth within 30 days prior to screening
•Current use of an occlusive wig, hair extensions or hair weaves
•History of hypersensitivity or allergies to any ingredient of study drug
•Poor peripheral venous access
•History clinically significant cardiac arrhythmia
•Unwilling to refrain form sperm donations
•Participation in another drug or device clinical study within 30 days or 5 half lives of the investigational agent prior to screening
•Subjects with pregnant partners at screening visit

发起方

Samumed Pacific Pty Ltd