NCT05525468

A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects

A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Technoderma Medicines Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years old

Detailed description

Protocol 239-13851-101 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-180935 Following Topical Administration in Healthy Male Subjects". Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo vs. placebo/placebo). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TDM-180935	TDM-180935 topical ointment
DRUG	Placebo	Placebo for TDM-180935 topical ointment

Timeline

• Start date: 2023-02-08
• Primary completion: 2023-08-18
• Completion: 2023-10-13
• First posted: 2022-09-01
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study