A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)

Recruiting at 1 trial location

Overseen By Zengquan Wang, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Technoderma Medicines Inc.

Must not be taking: CYP3A4 inhibitors, Systemic medications

Disqualifiers: Scalp disorders, Malignancy, HIV, others

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new scalp solution, TDM-105795, for treating hair loss in men aged 18-55 with Androgenetic Alopecia. Participants will use the solution regularly to see if it helps grow hair or stop further loss.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using systemic prescription medications, herbal supplements, and over-the-counter medications within 14 days before the trial starts, except for acetaminophen at less than 3g/day, which is allowed until 24 hours before the trial begins.

Research Team

Daniel Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Eligibility Criteria

Inclusion Criteria

Subject is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 6 months before Visit 2/Baseline.

Subject is male, 18-55 years old.

Subject has provided written informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive multiple dose administration of TDM-105795 or placebo applied daily to the scalp

6 weeks

4 visits (in-person) on days 1, 8, 15, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Placebo
• TDM-105795

Participant Groups

Group I: MAD Cohorts 1-4 TDM-105795 topical solution Experimental Treatment 1 Intervention

Multiple dose administration of TDM-105795 Topical Solution, 0.0025% or 0.005% or 0.01% or 0.02%

Group II: Placebo for TDM-105795 topical solution Placebo Group 1 Intervention

Multiple dose administration of Placebo forTDM-105795 Topical Solution

Who Is Running the Clinical Trial?

Technoderma Medicines Inc.

Lead Sponsor

Trials

5

Recruited

220+

Therapeutics, Inc.

Industry Sponsor

Trials

31

Recruited

3,900+