Efficacy and Safety of VDPHL01 in Males With AGA

Inclusion Criteria:

• Subject is male aged 18-65 years old;

• Subject has a clinical diagnosis of mild to moderate AGA;

• Subject is in good general health and has normal renal and hepatic function;

• Subject is willing to maintain at least 1/4 inch length hair during the study withthe same hairstyle, hair length, and hair color throughout the study; maintainconsistent use of general hair care products and regimen through the entire study;

• Subject is willing and able to administer the test article as directed read,understand, and complete required questionnaires in English;

• Subject is willing and able to swallow study drug whole;

• Subject agrees to have a micro dot tattoo placed on their scalp;

• Subject agrees to have this area photographed at study visits as indicated in theprotocol.

Exclusion Criteria:

• Subject has uncontrolled blood pressure or orthostatic hypotension;

• Subject has symptoms or history of certain heart or thyroid conditions;

• Subject has a history of or active hair loss due to conditions/diseases other thanAGA;

• Subject has a current or recent history of dietary or weight changes, including useof GLP-1 agonists;

• Subject has been diagnosed with COVID-19 within 16 weeks of screening;

• Subject has had previous radiation of the scalp;

• Use of any of the following treatments within the indicated washout period beforescreening:

• Subject has used hormone replacement therapy or hormonal modulators within 6months prior to screening

• Subject has used oral treatments for hair growth or that can affect hairgrowth, including systemic retinoids, within 6 months of screening

• Subject has used systemic calcium channel blockers or beta blockers within 12weeks prior to screening

• Subject has used systemic cimetidine, ketoconazole, diazoxide, orcorticosteroids (including intramuscular, intraarticular, and intralesionalinjections) within 12 weeks prior to screening

• Subject has had any scalp procedures, including surgical, laser, light orenergy treatments, micro-needling, injections, platelet rich plasma within 6months prior to screening

• Subject has used any topical scalp treatments for hair growth within 12 weeksprior to screening

• Subject has used any other therapy with any medication either topical or oral thatmight, in the investigator's opinion, interfere with the study;

• Subject has any other condition that, in the investigator's opinion, interfere withthe study