ACTRN12620000536965招募中1 期
A Continued Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of PLN-74809 in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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
- All
入选标准
- •1. 18 to 55 years
- •2. Good general health, with no significant medical history and no clinically significant abnormalities at screening and/or before administration of the initial dose of study drug.
- •3. Body weight greater than or equal to 50 kg
- •4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- •5. Participants must use adequate contraception measures for males and female participants of childbearing potential
- •6. Understand the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •- History of clinically significant abnormalities or diseases.
- •- Pregnant or lactating females.
- •- Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at screening.
- •- Positive toxicology screening panel.
- •- History of substance abuse or dependency or history of recreational drug use.
- •- Alcohol consumption greater than 14 drinks per week for males (7 for females).
- •- Smokers or ‘vapers’ (cigarette or other modalities).
- •- Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
- •- Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
- •- Have participated in any other investigational drug trial within 30 days or 5 half-lives.
研究者
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