Clinical trial NCT06454708: Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Day 1
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
timeFrame: Day 1
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Day 7
measure: Maximum plasma concentration at steady state (Cmax,ss)
timeFrame: Day 7
measure: Minimum plasma concentration at steady state (Cmin,ss)
timeFrame: Day 7
Secondary outcomes:
measure: AEs and SAEs
timeFrame: Day 7
measure: Temperature
timeFrame: Day 7
measure: Pulse rate
timeFrame: Day 7
measure: Blood pressure
timeFrame: Day 7
Other outcomes:
Locations:
city: London
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References: