Release time: 2022-01-05 Article source: TechnoDerma
SHANGHAI – January 5, 2022 Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that the Company has begun recruitment for its second Phase 1 clinical trial of topical TDM-105795 in patients with Androgenetic Alopecia (AGA). This follows successful completion of a single dose escalation study (NCT04913519), in which no material clinical safety issues were demonstrated based on reporting of adverse events, local skin reactions and changes from baseline in vital signs, safety labs, and ECG.
This second clinical trial is a 28-day multiple dose escalation study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia”. Its objectives are to evaluate topical TDM-105795 repeated dose safety and toleration and its pharmacokinetics, in order to define formulation strength(s) appropriate for a proof-of-concept Phase 2 study planned to follow.