drugset / Trial / NCT05380427

A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of CU-40101 Liniment in Single and Multiple Doses in Adult Male Androgenic Alopecia Subjects

NCT05380427 ↗

Phase 1 Completed 80 enrolled Cutia Therapeutics (Wuxi) Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

1. To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects; 2. To evaluate the pharmacokinetic (PK) characteristics of CU-40101 liniment administered as a single and multiple topical skin application in adult male subjects with androgenic alopecia.

Timeline

Start
2022-08-15
Primary completion
2023-11-15
Completion
2024-02-22

Outcome

Met primary endpoint

release “CU-40101 (topical small molecule thyroid hormone receptor agonist liniment) conducted in China for the treatment of androgenetic alopecia reached primary endpoint.” cutiatx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CU-40101 Unknown 0.0025 % Topical
Subject CU-40101 Unknown 0.005 % Topical
Subject CU-40101 Unknown 0.01 % Topical
Subject CU-40101 Unknown 0.02 % Topical
Subject CU-40101 Unknown 0.05 % Topical

Indications