A Phase 1, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Japanese and Chinese Participants.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
研究概览
简要总结
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of JADE101 in healthy Japanese and Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants 18-55 years of age, inclusive
- •First-generation Japanese or Chinese participants born in Japan/China
- •A body weight between 40-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening
- •Willing and able to comply with the study site stay, scheduled visits, and study procedures
- •Willing and able to comply with contraceptive and lifestyle requirements from admission through the end of the study
排除标准
- •Harmful alcohol use
- •Smoking/vaping or heavy tobacco use within 2 years prior to screening
- •Known history of abuse of illicit drugs
- •Nursing, lactating or pregnant, or who have plans to become pregnant during the study
- •Known history of clinically significant disease
- •Known history of immunodeficiency disorder
- •History of clinically significant allergic reactions or hypersensitivity
研究组 & 干预措施
JADE101 Groups 1 and 2
Subcutaneous (SC) injection of JADE101
干预措施: JADE101 (Drug)
JADE101 Groups 3 and 4
Subcutaneous (SC) injection of JADE101
干预措施: JADE101 (Drug)
结局指标
主要结局
Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
时间窗: Day 1 through 48 weeks
Incidence of treatment-emergent adverse events
Cmax
时间窗: Day 1 through 48 weeks
Maximum observed serum concentration
Tmax
时间窗: Day 1 through 48 weeks
Time to reach Cmax
AUClast
时间窗: Day 1 through 48 weeks
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
T1/2
时间窗: Day 1 through 48 weeks
Apparent first-order terminal elimination half-life
次要结局
- Immunogenicity of JADE101 in healthy Japanese and Chinese participants(Day 1 through 48 weeks)