A Double-blind, Randomised, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple-ascending Doses of Intravenously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Single-ascending and Multiple Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Patient Volunteers With Hypertriglyceridemia.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in otherwise healthy volunteers with elevated triglyceride levels
详细描述
The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs >150mg/dL. Part B is up to 4 multiple ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs >150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort of patient volunteers with TRG >200mg/dL who will receive 3 doses at 2 week intervals of STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058. Part E will recruit a single cohort of otherwise healthy volunteers with TRG > 150mg/dL to receive 4 doses subcutaneously of STT-5058 over 4 weeks
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, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •in good health
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception Parts A, B and D
- •BMI between 18 and 35 kg/m2 inclusive
- •Fasting Triglycerides between 150 and 400mg/dL inclusive Part C
- •Fasting Triglycerides between 200 and 400 mg/dL inclusive
- •Fasting LDL-C between 70 and 160 mg/dL inclusive
- •BMI between 18 and 40 kg/m2
排除标准
- •significant history or clinical manifestation of metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator
- •Confirmed (eg, 2 consecutive measurements) systolic blood pressure >150 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and heart rate >90 or <40 beats per minute at Screening, Check-in, or prior to dosing on Day
- •History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (if known), whichever is longer, prior to dosing.
研究组 & 干预措施
STT-5058
干预措施: STT-5058 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 10 weeks
incidence and severity of adverse events
次要结局
- AUC(10-14 weeks)
- Cmax(24 hours)
- Half life(10-14 weeks)