NCT06454708已完成1 期
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
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Clascoterone Cream 1%
Experimental
干预措施: Clascoterone Cream 1% (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: Day 1
Maximum plasma concentration
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
时间窗: Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Maximum plasma concentration at steady state (Cmax,ss)
时间窗: Day 7
Maximum plasma concentration at steady state
Time to maximum plasma concentration (Tmax)
时间窗: Day 7
Time to maximum plasma concentration
Minimum plasma concentration at steady state (Cmin,ss)
时间窗: Day 7
Minimum plasma concentration at steady state
次要结局
- AEs and SAEs(Day 7)
- Temperature(Day 7)
- Blood pressure(Day 7)
- Pulse rate(Day 7)
研究者
研究点 (1)
Loading locations...
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