A Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Transdermal Doses of SFG-02 in Japanese and White Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of a novel transdermal formulation of SFG-02 following single and repeated applications in Japanese and White healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy Japanese or white male and female participants aged between 18 and 45 years at the time of consent.
- •Participants who agree to use contraception during a specified period.
- •Participants with a Body Mass Index (BMI) of at least 18.0 kg/m2 and less than 32.0 kg/m
- •Participants who are judged to be healthy by the principal (or sub-) investigator.
- •Participants must understand the methods and compliance requirements of this study and must give his/her free and voluntary written consent to participate in this study.
排除标准
- •Participants with clinically relevant symptoms, diseases, or pre-existing conditions.
- •Participants with extensive skin findings on the abdomen.
- •Participant who has used or will use prescription drugs, non-prescription drugs or products containing herbal medicines within a specified period
- •Participants whose normal weekly alcohol intake exceeds 150 g.
- •Habitual consumers of caffeine-containing beverages who are likely to experience symptoms if they stop.
- •Smokers or those who have smoked or used other nicotine-containing products within 6 months.
- •Participants who participated in a clinical trial and took a new active pharmacological ingredient within a specified period.
- •Participants who have undergone surgery within 4 weeks.
- •Pregnant or lactating women.
研究组 & 干预措施
(4) SFG-02 Single Transdermal Application (White)
Assign 8 White Participants for SFG-02 or Placebo Application (single)
干预措施: SFG-02 (Drug)
(4) SFG-02 Single Transdermal Application (White)
Assign 8 White Participants for SFG-02 or Placebo Application (single)
干预措施: Placebo (Drug)
(1) SFG-02 Single Transdermal Application
Assign 8 Japanese Participants for SFG-02 or Placebo Application
干预措施: SFG-02 (Drug)
(1) SFG-02 Single Transdermal Application
Assign 8 Japanese Participants for SFG-02 or Placebo Application
干预措施: Placebo (Drug)
(2) SFG-02 (1st) Repeated Transdermal Application for 10 days
Assign 8 Japanese Participants for SFG-02 1st Dose or Placebo Application (10 days)
干预措施: SFG-02 (Drug)
(2) SFG-02 (1st) Repeated Transdermal Application for 10 days
Assign 8 Japanese Participants for SFG-02 1st Dose or Placebo Application (10 days)
干预措施: Placebo (Drug)
(3) SFG-02 (2nd) Repeated Transdermal Application for 10 days
Assign 8 Japanese Participants for SFG-02 2nd Dose or Placebo Application (10 days)
干预措施: SFG-02 (Drug)
(3) SFG-02 (2nd) Repeated Transdermal Application for 10 days
Assign 8 Japanese Participants for SFG-02 2nd Dose or Placebo Application (10 days)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: From the first application to the 14th day after the final application
Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects
Pharmacokinetics (PK): Maximum concentration (Cmax) of SFG-02
时间窗: At designated timepoints (up to 7 days after the final application)
Blood samples will be collected at multiple timepoints to estimate Cmax of SFG-02
PK: Area under the concentration versus time curve (AUC) of SFG-02
时间窗: At designated timepoints (up to 7 days after the final application)
Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02
PK: Time to maximum concentration (Tmax) of SFG-02
时间窗: At designated timepoints (up to 7 days after the final application)
Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02
PK: Time to decrease the concentration by half (T1/2) of SFG-02
时间窗: At designated timepoints (up to 7 days after the final application)
Blood samples will be collected at multiple timepoints to estimate T1/2 of SFG-02
次要结局
未报告次要终点