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

NCT06454708 | Completed Phase 1

• 1 other identifier: LWY23090P
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• AEs and SAEs

  Day 7

• Temperature

  Day 7

• Pulse rate

  Day 7

• Blood pressure

  Day 7

Study Arms (1)

Clascoterone Cream 1%

EXPERIMENTAL

Drug: Clascoterone Cream 1%

Interventions

Clascoterone Cream 1% DRUG

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

Clascoterone Cream 1%

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese adult subjects, male or female;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Huashan Hospital, Fudan University

London, N1 9JP, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 12, 2024
• Study Start: August 1, 2024
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: January 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)