A First-in-Human,Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation,Phase 1 Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of AK102 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent AE
研究概览
简要总结
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
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
- Triple (Participant, Care Provider, 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
- •Signed Informed Consent.
- •No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
- •Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
- •Body mass index (BMI) ≥18 and ≤ 28 kg/m^2 , body weight >= 50 kg for male or >= 45 kg for female.
排除标准
- •Triglyceride concentration >400 mg/dL (4.5 mmol/L).
- •History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
- •Drug or alcohol abuse within 6 months prior to dosing.
- •Blood pressure >140 mmHg (systolic) or > 90 mmHg (diastolic)
研究组 & 干预措施
Placebo
Matching placebo
干预措施: Placebo (Drug)
AK102 500mg
AK102 500mg
干预措施: AK102 (Drug)
AK102 75mg
AK102 75mg
干预措施: AK102 (Drug)
AK102 150mg
AK102 150mg
干预措施: AK102 (Drug)
AK102 300mg
AK102 300mg
干预措施: AK102 (Drug)
结局指标
主要结局
Incidence of treatment emergent AE
时间窗: From single dose of AK102 through 12 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
次要结局
- Pharmacokinetic characteristics of AK102(over 12 weeks)
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)(At different time points from baseline through 12 weeks)
- Percent Change From Baseline in PCSK9(At different time points from baseline through 12 weeks)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(At different time points from baseline through 12 weeks)