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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Clascoterone Cream 1%

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • London, China, N1 9JP
    • Huashan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clascoterone Cream 1%	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum plasma concentration (Tmax)	Time to maximum plasma concentration	Day 1
Maximum plasma concentration (Cmax)	Maximum plasma concentration	Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)	Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration	Day 1
Time to maximum plasma concentration (Tmax)	Time to maximum plasma concentration	Day 7
Maximum plasma concentration at steady state (Cmax,ss)	Maximum plasma concentration at steady state	Day 7
Minimum plasma concentration at steady state (Cmin,ss)	Minimum plasma concentration at steady state	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs and SAEs	Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs), and their relevance with the investigational drug.	Day 7
Temperature	Incidence of abnormal clinically significant temperature results.	Day 7
Pulse rate	Incidence of abnormal clinically significant pulse rate results.	Day 7
Blood pressure	Incidence of abnormal clinically significant blood pressure results.	Day 7

Collaborators and Investigators

• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: LWY23090P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No