A Phase 1 Study of TDM-105795 Topical Solution in Male Subjects With Androgenetic Alopecia (AGA)

Inclusion Criteria

• •To enter the study, a subject must meet the following criteria:
• •1. Subject is male, 18-55 years old.
• •2. Subject has provided written informed consent.
• •3. Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, IIIv to VI on the Modified Norwood-Hamilton Scale (i.e., IIIv, IV, V, and VI).
• •4. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
• •5. 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.
• •6. Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
• •7. 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 6 months before Visit 2/Baseline.
• •8. Subject has a body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg at Visit 1/Screening.
• •9. 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.
• •10. 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 1 week following initiation of study treatment and inform their female sexual partner to use a highly effective form of birth control as described in the informed consent form. For females, highly effective forms of birth control include 1) intrauterine device (IUD; copper or hormonal); 2) implantable hormonal contraception; 3) surgical sterilization (i.e., hysterectomy, tubal ligation, or bilateral oophorectomy) performed at least 6 months prior to the subject's study entry; 4) total abstinence; or 5) using one of each of the following a) hormonal contraceptives \[other than IUD or implantable, e.g., oral, transdermal, injectable, or vaginal ring\] and b) double barrier methods \[i.e., male or female condom, diaphragm with spermicidal foam/gel/film/cream/vaginal suppository, cervical cap with spermicides, or contraceptive sponge\]. Male subjects who become sexually active or begin to have relations with a female partner who is not sterile during the trial must have a female partner who agrees to use a highly effective form of birth control for the duration of the subject's participation in the trial. Female partner taking hormonal therapy must be on treatment prior to the subject's entry into the study, continued per label, and must not change their dosing regimen during the trial; highly effective birth control forms must be for (1) oral: at least 1 complete cycle (e.g., 4 to 8 weeks); (2) transdermal, injectable (e.g., Depo-Provera), implantable, vaginal ring (e.g., NuvaRing), IUD: at least 1 week; or (3) total abstinence: at least 1 complete cycle (e.g., 4 to 8 weeks) prior to initiation of test article. For males, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception.