ACTRN12623001117606招募中1 期
A Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of YA-101 in Healthy Subjects
Yoda Pharmaceuticals Aus Pty Ltd0 个研究点目标入组 60 人开始时间: 2023年10月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Subjects 18 to 65 years of age (inclusive) and in good state of health.
- •2. Must be able to communicate and participate in the whole study.
- •3. Must provide written informed consent.
排除标准
- •1. Subject who has received any investigational drug, stem cell therapy, or inactivated/live vaccinations within 30 days.
- •2. Subject who is an employee or immediate family member of the Sponsor or the study site.
- •3. History of drug, alcohol, or smoking abuse in the past 2 years prior to screening.
- •4. Tested positive for drug abuse.
- •5. Unwilling to refrain from the use of any prescription medications.
- •6. Subject not suitable for multiple venipunctures.
- •7. Has clinically significant abnormal clinical chemistry, hematology, urinalysis, or tested positive for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at screening.
- •8. Has clinical history or evidence of allergic, hematological, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, psychiatric disease, or malignancy.
- •9. Any other condition which is deemed unsuitable for participating in the study.
研究者
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