NCT02538848已完成1 期
A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence, severity and causality of adverse events
研究概览
简要总结
To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers
详细描述
Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •For volunteers in SAD:
- •Inclusion Criteria:
- •Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
- •Non-diabetic, fasting plasma glucose < 5.6 mmol/L
- •Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months.
- •Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of Study Drug.
- •Ability to provide written informed consent.
排除标准
- •Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at screening.
- •Pregnant or lactating women
- •Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
- •Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. Use of ≤2g paracetamol per day is allowed prior to and during the study at Investigator discretion.
- •Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
- •History of any major surgery within 6 months prior to Screening
- •History of any serious adverse reaction or hypersensitivity to any of the product components.
- •Use of parenterally administered proteins or antibodies within 12 weeks of screening.
研究组 & 干预措施
300mg in SAD
Experimental
single dose of 300mg HTD4010 or placebo injectable in healthy volunteers
干预措施: HTD4010 (Drug)
100mg in SAD
Experimental
single dose of 100mg HTD4010 or placebo injectable in healthy volunteers
干预措施: HTD4010 (Drug)
200mg in SAD
Experimental
single dose of 200mg HTD4010 or placebo injectable in healthy volunteers
干预措施: HTD4010 (Drug)
50mg in SAD
Experimental
single dose of 50mg HTD4010 or placebo injectable in healthy volunteers
干预措施: HTD4010 (Drug)
结局指标
主要结局
Incidence, severity and causality of adverse events
时间窗: One day in SAD
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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