A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 79
- 试验地点
- 18
- 主要终点
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The subjects and the investigative site staff, except for the unblinded pharmacist, will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with ages between 18 and 70 years old, inclusive.
- •Protocol-defined elevated plasma Lp(a) level.
- •Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
- •Women must be of non-reproductive potential.
- •Other Inclusion criteria may apply
排除标准
- •Currently receiving treatment in another investigational device or drug study.
- •Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
- •History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •History or clinical evidence of bleeding diathesis or any coagulation disorder.
- •History or clinical evidence of peripheral neuropathy.
- •Other Exclusion criteria may apply
研究组 & 干预措施
Placebo
Single Ascending Dose Cohorts
干预措施: Placebo (Drug)
AMG 890
Single Ascending Dose Cohorts
干预措施: AMG 890 (Drug)
结局指标
主要结局
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
时间窗: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
次要结局
- Maximum Observed Concentration (Cmax) of Olpasiran(Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose)
- Time to Reach Cmax (Tmax) of Olpasiran(Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose)
- Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran(Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose)
- Change From Baseline in Plasma Lp(a) Levels(Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365)
- Percent Change From Baseline in Plasma Lp(a) Levels(Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365)