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:

1. Subject is male, 18-55 years old.

2. Subject has provided written informed consent.

3. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia (AGA) intemple and vertex region with a score of IIIv, IV, or V on the ModifiedNorwood-Hamilton Scale.

4. Subject, in the investigator's opinion, is in good general health and free of anydisease state or physical condition that might impair evaluation of AGA or exposesthe subject to an unacceptable risk by study participation.

5. Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.

6. Subject is a non-smoker, defined as not having smoked or used any form of tobacco ornon-tobacco products containing nicotine in more than 4 months before Visit 2/Baseline.

7. Subject is willing to maintain the same hair style, hair length, and hair colorthroughout the study.

8. Subject agrees to continue his other general hair care products and regimen for atleast 2 weeks prior to Visit 2/Baseline, and through the entire study.

9. 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 durationof the study.

10. Subjects who are sexually active with a female partner and are not surgicallysterile ( vasectomy performed at least 6 months prior to treatment) must agree torefrain from sperm donation for at least 90 days after administration of their lastdose of IP and inform their non-pregnant female sexual partner to use a highlyeffective 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 newsexual partner.

Exclusion Criteria:

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

1. Subject has any dermatological disorders of the scalp on the regions that are baldand thinning with the possibility of interfering with the application of the IP orexamination method, such as fungal or bacterial infections, seborrheic dermatitis,psoriasis, eczema, folliculitis, scars, or scalp atrophy.

2. Subject has history or active hair loss due to diffuse telogen effluvium, alopeciaareata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.

3. Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease,certain genetic disorders that involve hair growth or patterns) that, in theinvestigator's opinion, could interfere with the evaluation of the IP or requiresuse of interfering topical, systemic, or surgical therapy.

4. Subject has any visible inflammatory skin disease, injury, or condition of theirscalp that could compromise subject safety and/or interfere with the evaluation oflocal or systemic assessments performed during the study.

5. Subject has history (within 6 months of Visit 1/Screening) of severe dietary orweight changes or history of eating disorder(s), which has resulted in hair loss, inthe opinion of the investigator.

6. Subject has a history of scalp reduction or notable trauma with related scarring,hair transplants, and/or hair weaves.

7. Subject has a known or suspected malignancy excluding cutaneous basal cell carcinomaor cutaneous squamous cell carcinoma not located within the treatment area.

8. Subject has a positive blood screen for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibody.

9. Subject has any condition, which, in the investigator's opinion, would make itunsafe for the subject to participate in this study, including clinicallysignificant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings duringthe screening period or Visit 2/Baseline prior to dosing of the IP.

10. Subject has used any topical scalp treatments for hair growth including minoxidil,hormone therapy, anti-androgen, or other agents known to affect hair growth within 12 weeks of Visit 2/Baseline.

11. Subject has used any topical scalp over-the-counter (OTC) or cosmetic treatmentsknown or reasonably believed to affect hair growth (e.g., brands such as Aminexil,Maxilene, Nioxin, Foltene) or hair growth products with saw palmetto, copper, etc.within 4 weeks of Visit 2/Baseline.

12. Subject has used any topical scalp treatments that may have ancillary effects onhair growth including, but not limited to, corticosteroids, pimecrolimus,tacrolimus, and retinoids within 4 weeks of Visit 2/Baseline.

13. Subject has had any scalp procedures, including surgical, laser, light or energytreatments, micro-needling, etc. within 6 months of Visit 2/Baseline.

14. Subject has had platelet rich plasma (PRP) procedures on the scalp at any time.

15. Subject has used systemic beta blockers, cimetidine, ketoconazole, diazoxide, orcorticosteroids (including intramuscular and intralesional injections) within 12weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids areallowed if use is stable. Stable is defined as doses and frequency unchanged for atleast 4 weeks prior to Visit 2/Baseline.

16. Subject has used systemic retinoids, isotretinoin, vitamin A intake above 10,000 IUper day, or cyclosporine therapy within 6 months of Visit 2/Baseline.

17. Subject has used finasteride (e.g., Propecia®), dutasteride, minoxidil (oral), orsimilar products within 6 months of Visit 2/Baseline.

18. Subject has used chemotherapy or cytotoxic agents within 12 months of Visit 2/Baseline.

19. Subject has had radiation of the scalp at any point.

20. Subject has used any other systemic therapy, which in the opinion of theinvestigator, may materially affect the subject's hair growth, including, but notlimited to, vitamin or homeopathy supplement hair growth or hair health products orother steroid hormones (in any form), including anabolic steroids.

21. Subject is currently enrolled in an investigational drug, biologic, or device study.

22. Subject has used an investigational drug, investigational biologic, orinvestigational device treatment within 30 days or 5 half-lives, whichever islonger, prior to Visit 2/Baseline.

23. Subject has previously been treated with the IP.

24. Subject has a history of prescription drug abuse, or illicit drug use within 6months prior to Visit 1/Screening.

25. Subject has a history of alcohol abuse according to medical history within 6 monthsprior to Visit 1/Screening.

26. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening orVisit 2/Baseline.

27. Subject has signs or symptoms consistent with Coronavirus Disease-19 (COVID-19) atVisit 1/Screening or Visit 2/Baseline or has been diagnosed with COVID-19 within 4weeks of Visit 1/Screening.

28. Subject has a history of sensitivity to any of the ingredients in the IP or tattooink.

29. Subject is known to be noncompliant or is unlikely to comply with the requirementsof t the study protocol (e.g., due to alcoholism, drug dependency, mentalincapacity) in the opinion of the investigator.