NCT06454708

Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects

An Open Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Dose and Repeat Dose Topical Administrations of Clascoterone Cream, 1% in Healthy Chinese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clascoterone Cream 1%	Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2024-06-12
• Last updated: 2025-01-28

Locations

1 site across 1 country: China