Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia

• Status: Not yet recruiting
• Trial end date: 2023-07-17
• Target enrollment: 0
• Participant gender: Male

Summary

This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aneira Pharma, Inc.
• Collaborator: DataPharm Australia, CMAX Clinical Research, Agilex Australia
• Treatments: Latanoprost; Minoxidil

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.