NCT02558413已完成1 期
A Double-Blind, Placebo-Controlled, Single 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 60 人开始时间: 2015年8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
- 60
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to 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 aged 18-60 years;
- •Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
- •Female subjects must be of non-childbearing potential;
- •Male subjects must agree to use a double barrier method of birth control;
- •Able to provide informed consent
排除标准
- •Current or recent (within 14 days of Day 0) bacterial or viral infection;
- •Positive results for hepatitis B, hepatitis C, or HIV;
- •Clinically significant abnormalities noted on ECG;
- •Safety laboratory abnormalities;
- •Regular use of medications, prescription or non-prescription;
- •Poor vein access or fear of venipuncture;
- •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
25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 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
Number of adverse events
时间窗: Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
时间窗: 0-24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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