NCT04913519

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Technoderma Medicines Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Alopecia, Androgenetic

Interventions

Type	Name	Description
DRUG	TDM-105795	TDM-105795 topical solution
DRUG	Placebo	Placebo for TDM-105795 topical solution

Timeline

• Start date: 2021-04-27
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-06-04
• Last updated: 2022-04-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study