NCT02668367已完成1 期
A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
Biota Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
研究概览
简要总结
This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women;
- •Age 18 to 60 years, inclusive;
- •Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
- •Female subjects must be of non-childbearing potential;
- •Male subjects must agree to use a double barrier method of birth control;
- •Signed informed consent form (ICF) prior to study procedures.
排除标准
- •Current or recent (within 14 days of Day 0) bacterial or viral infection;
- •Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
- •Clinically significant abnormalities noted on ECG;
- •Safety laboratory abnormalities;
- •Regular use of medications, prescription or non-prescription;
- •Poor vein access or fear of venipuncture or sight of blood;
- •Major surgery, significant recent injury or trauma within 30 days;
- •Received an investigational drug or vaccine within 30 days.
研究组 & 干预措施
BTA-C585 oral capsules
Active Comparator
100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg
干预措施: BTA-C585 oral capsules (Drug)
BTA-C585 matching placebo
Placebo Comparator
BTA-C585 Matching placebo capsules; single doses
干预措施: BTA-C585 matching placebo (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
时间窗: 0-24 hours
Number of adverse events
时间窗: Day -1 to Day 14
次要结局
未报告次要终点
研究者
研究点 (1)
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