A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects
brief 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.
official title
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