NCT07590193招募中1 期
A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 162
- 试验地点
- 2
研究概览
简要总结
The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Part A and B
- •Participant must be 18-65 years of age
- •Participant must be overtly healthy
- •Inclusion Criteria for Part C
- •Participant must be 40-75 years of age
- •Confirmed diagnoses of T2DM
排除标准
- •for Part A and B
- •History of hypotension, syncope, or orthostatic intolerance
- •Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg
- •Exclusion Criteria for Part C
- •Hemoglobin A1c (HbA1c) >10% within the last 3 months
- •History of hypotension, syncope, or orthostatic intolerance
- •Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
研究组 & 干预措施
Part A: Single Ascending Dose (SAD)
Experimental
Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.
干预措施: AMG 127 (Drug)
Part B: Multiple Ascending Dose (MAD)
Experimental
Participants will receive multiple ascending doses of AMG 127 via SC injection.
干预措施: AMG 127 (Drug)
Placebo
Placebo Comparator
Participants will receive a matching placebo as either a SC injection or as an IV infusion.
干预措施: Placebo (Drug)
Part C: Proof of Mechanism (PoM)
Experimental
Participants will receive multiple doses of AMG 127 via SC injection.
干预措施: AMG 127 (Drug)
结局指标
主要结局
未指定
次要结局
- Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus(Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days))
研究者
研究点 (2)
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