A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 529 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
- •Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
- •Women must be of non-reproductive potential as defined in protocol
- •Other inclusion criteria may apply
排除标准
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
- •Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
- •Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
- •Positive pregnancy test at screening or day -1
- •Other exclusion criteria may apply
研究组 & 干预措施
AMG 529
Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.
干预措施: AMG 529 (Drug)
Placebo
Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal. A serious adverse event was defined as an adverse event that met at least 1 of the following criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
次要结局
- Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time(Baseline and days 3, 8, and 30)
- Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time(Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.)
- Maximum Observed Concentration (Cmax) of AMG 529(Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.)
- Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529(Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.)
- Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time(Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.)
- Change From Baseline in Triglycerides Concentration Over Time(Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.)
- Time to Maximum Observed Concentration (Tmax) of AMG 529(Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.)
- Change From Baseline in Total Cholesterol Concentration Over Time(Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.)