A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects With Elevated Triglycerides
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
A first time in man study of NST-1024
详细描述
A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18-32 kg/m2
- •In good health
- •Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception
- •Male subjects must agree to use contraception and refrain from donation of sperm
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •Subjects must have TG levels > 150 mg/dL at screening (Part B only).
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- •Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin > 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary
- •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 (whichever is longer) prior to dosing.
- •Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.
研究组 & 干预措施
NST-1024
NST-1024 capsules given once daily for up to 14 days
干预措施: NST-1024 (Drug)
Placebo
Matching placebo capsules to NST-1024 given once daily for up to 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 4 weeks
incidence and severity of adverse events
次要结局
- AUC(3-17 days)
- Cmax(3-17 days)
- Half life(3-17 days)