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

NCT ID: NCT06454708

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-08-12

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clascoterone Cream 1%

Group Type: EXPERIMENTAL

Clascoterone Cream 1%

Intervention Type: DRUG

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

Interventions

Clascoterone Cream 1%

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chinese adult subjects, male or female;
• 18-45 years of age (18 years old and 45 years old are inclusive, on the day of signing the written informed consent);
• Males should be ≥50.0 kg females should be ≥45.0 kg, respectively, and their body mass index [BMI = weight (kg)/height2 (m2)] should be within the range of 19.0 to 28.0 kg/m2 (including critical value);
• Female subjects of childbearing potential or male subjects whose partners are of childbearing potential should agree and be able to use effective contraception from the time of signing the written informed consent to within 3 months after the last dosing (see Appendix 2 for details);
• Subjects should be able to communicate well with the investigator and complete the study as per the protocol; subjects should be fully informed about the study and sign a written informed consent voluntarily.

Exclusion Criteria

• Subject has a previous history of chronic or serious disease;
• Subject who has undergone major surgical procedure or procedure affecting drug absorption, distribution, metabolism, or excretion within 6 months prior to screening, or plans to undergo surgery during the study;
• Subject has a history of drug abuse and drug dependence;
• Subject who has received any medication prior to screening;
• Subject has previous allergies or has allergic symptoms;
• Subject has skin damages;
• Subject who has consumed alcohol regularly;
• Subject has positive testing result of drug abuse and narcotics screening ;
• Subject who has consumed excessive of strong tea, coffee, or caffeine-containing beverages;
• Subject who has been addicted to smoking;
• Subject who has intake of grapefruit-rich beverages or foods;
• Subject who has participated in a clinical study with another drug or device and has used the drug or device prior to screening
• Subject who has donated blood or bled heavily , or received a blood transfusion or used blood products; or who plans to donate blood or blood components;
• Subject has abnormal physical examination result at screening, or abnormal result of vital signs, or abnormal ECG findings;
• Subject has abnormal and clinically significant results of clinical laboratory tests;
• Subject who is a pregnant or lactation woman or has positive pregnancy test result;
• Subject who is unable to follow a uniform diet;
• Subject who has difficulty in collecting blood, has a history of needle and blood fainting or cannot tolerate venipuncture;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan University

London, , China

Countries

China

Other Identifiers

LWY23090P

Identifier Type: -

Identifier Source: org_study_id