ACTRN12623000448640招募中1 期
An Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 Intravenous Dose and Infusion Rates
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy males and females, aged 18-65 (inclusive) at screening with suitability confirmed by way of screening assessments.
- •Body mass index (BMI) between 18 and 35 kg/m² (inclusive) and body weight not less than 50 kg and no more than 120kg.
- •Women of childbearing potential (WOCBP) must agree to follow instructions for highly effective contraceptive method(s) of contraception for the duration of treatment with study drug plus 30 days after the last study drug administration.
- •Must agree to urethral catheterisation of the bladder for each dosing period which will be placed 2 hours pre dose and removed at 6 hours post dose.
排除标准
- •Currently pregnant or breastfeeding women.
- •History or current phlebitis or thrombophlebitis.
- •History or current clinically significant medical history or condition.
- •Use of any investigational products within 30 days prior first dose of RECCE®327.
- •Alcohol or substance abuse within the past 6 months prior to screening.
- •Receipt of any vaccination within 14 days prior the first study dose administration.
研究者
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