Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia

Inclusion Criteria

To enter the study, a subject must meet the following criteria:

• Subject is male, 18-55 years old.
• Subject has provided written informed consent.
• Subject has a clinical diagnosis of mild to moderate androgenetic alopecia (AGA) in temple and vertex region with a score of IIIv, IV, or V on the Modified Norwood-Hamilton Scale.
• Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of AGA or exposes the subject to an unacceptable risk by study participation.
• Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
• Subject is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 4 months before Visit 2/Baseline.
• Subject is willing to maintain the same hair style, hair length, and hair color throughout the study.
• Subject agrees to continue his other general hair care products and regimen for at least 2 weeks prior to Visit 2/Baseline, and through the entire study.
• Subject is willing and able to apply the investigational product (IP) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
• Subjects who are sexually active with a female partner and are not surgically sterile ( vasectomy performed at least 6 months prior to treatment) must agree to refrain from sperm donation for at least 90 days after administration of their last dose of IP and inform their non-pregnant female sexual partner to use a highly effective form of birth control1 as described in the informed consent form. Note: Female partner must be confirmed according to subject to be non-pregnant at Visit 1/Screening and Visit 2/Baseline or at the visit when a subject identifies a new sexual partner.

Exclusion Criteria

A subject is ineligible to enter the study if he meets 1 or more of the following criteria:

• Subject has any dermatological disorders of the scalp on the regions that are bald and thinning with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
• Subject has history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
• Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns) that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy.
• Subject has any visible inflammatory skin disease, injury, or condition of their scalp that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
• Subject has history (within 6 months of Visit 1/Screening) of severe dietary or weight changes or history of eating disorder(s), which has resulted in hair loss, in the opinion of the investigator.
• Subject has a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
• Subject has a known or suspected malignancy excluding cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma not located within the treatment area.
• Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of th