ACTRN12618001851257已完成1 期
A randomized, double-blind, placebo-controlled study to assess the safety and tolerability of PN-1094A after single and multiple ascending doses of PN-10943A in normal healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 97
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Normal healthy volunteers 18-55 years
- •Good general health,
- •BMI 18-30kg/m2
- •Non-smokers
- •Lab values within normal range. Willing to consume standard meal provided.
- •Ability and willingness to attend visits to the site and provide written informed consent prior to entry into the study.
排除标准
- •History of significant abnormalities or diseases
- •Clinical significant lab or ECG abnormalities
- •Mentally or legally incapacitated
- •History of substance abuse, severe allergic or anaphylactic reactions. Regular Alcohol consumption (>21units per week).
- •Inability to comply with the requirements of the study protocol
研究者
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