A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants
研究概览
简要总结
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 compared to placebo in healthy participants.
详细描述
This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE101 in healthy participants. The study will enroll approximately 32 healthy volunteers. JADE101 will be administered by a subcutaneous injection. The results of this study will help inform the dosing and frequency of dosing in future studies of JADE101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •A body weight between 50-100 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 using two methods of contraception (one being highly effective) 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
Subcutaneous (SC) injection of JADE101
干预措施: JADE101 (Drug)
Placebo
Subcutaneous (SC) injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants
时间窗: Day 1 through 48 weeks
Incidence of treatment-emergent adverse events
次要结局
- Tmax(Day 1 through 48 weeks)
- Cmax(Day 1 through 48 weeks)
- AUClast(Day 1 through 48 weeks)
- T1/2(Day 1 through 48 weeks)