Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia
Androgenetic Alopecia
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
Inclusion Criteria: Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are: Migraines Non-hospitalized depression o Asthma Cholecystectomy Gilbert's syndrome Clinical diagnosis of AGA with grade II to VI hair loss on Norwood Hamilton Classification System Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator's opinion, interfere with study assessments. No known allergy to ANR-001.1 or any of its components. Subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study. Exclusion Criteria: If subjects have a BMI outside of the range of 18-35kg/m2 Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study. Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator. Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation. Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.). Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment. Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Primary safety and pharmacokinetic data
To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp