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

Alopecia, Androgenetic Clinical Trial

Official title:
A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Dose TDM-105795 Topical Solution in Healthy Male Subjects With AGA

Clinical Trial Summary

Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group, dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).

Clinical Trial Description

Protocol 239-11651-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration in Healthy Male Subjects with Androgenetic Alopecia". Eligible subjects will be assigned to a sequential treatment cohort and will receive either one of the TDM-105795 solutions or the Placebo. The assigned test article will be applied once onto the scalp in the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1 mL of test article with application to the scalp focusing on the regions that are bald and thinning. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04913519
Study type Interventional
Source Technoderma Medicines Inc.
Contact
Status Completed
Phase Phase 1
Start date April 27, 2021
Completion date December 31, 2021
View Details
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