A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
详细描述
This Phase 1 ethnobriding study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females, aged 18 to 65 years
- •25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
- •Meet the criteria for Japanese, Chinese, or Caucasian ethnicity
排除标准
- •Participating or have participated in another clinical trial within the past 6 months
- •Any bone fracture within the past 6 months
- •History of myocardial infarction or stroke within the past 12 months
- •Malignancy within the past 5 years
- •Current hyper- or hypocalcemia
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study
研究组 & 干预措施
Cohort 1 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118.
干预措施: AGA2118 (Drug)
Cohort 5 (Chinese)
Healthy Chinese participants will receive a single administration of high dose AGA2118.
干预措施: AGA2118 (Drug)
Cohort 2 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118.
干预措施: AGA2118 (Drug)
Cohort 4 (Caucasian)
Healthy Caucasian participants will receive a single administration of high dose AGA2118.
干预措施: AGA2118 (Drug)
Cohort 3 (Japanese)
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118.
干预措施: AGA2118 (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: Day 1 to up to the end of study (85 days post-dose)
Cmax of AGA2118 after dosing
Time to maximum concentration (Tmax)
时间窗: Day 1 to up to the end of study (85 days post-dose)
Tmax of AGA2118 after dosing
Area under the concentration-time curve (AUC)
时间窗: Day 1 to up to the end of study (85 days post-dose)
AUC of AGA2118 after dosing
Half-life (t1/2)
时间窗: Day 1 to up to the end of study (85 days post-dose)
t1/2 of AGA2118 after dosing
Clearance (CL)
时间窗: Day 1 to up to the end of study (85 days post-dose)
CL of AGA2118 after dosing
Volume of distribution (Vd)
时间窗: Day 1 to up to the end of study (85 days post-dose)
Vd of AGA2118 after dosing
次要结局
- Treatment-emergent adverse events (TEAEs)(Baseline to the end of study (85 days post-dose))