ACTRN12624000562572招募中1 期
A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics with Single and Multiple Oral Doses of SIR2501 in Healthy Adult Participants
Sironax Australia Pty Ltd0 个研究点目标入组 112 人开始时间: 2024年5月3日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
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
- •Must be capable of giving a signed informed consent
- •Participants in good health based on medical history, physical examinations, vital
- •signs, 12-lead ECGs, clinical laboratory tests as determined by the Investigator.
- •Body mass index (BMI) within the range of 18~32 kg/m2 (inclusive) with a minimum
- •body weight of 50 kg at the screening visit.
- •Adhere to effective double barrier contraception or are proven post-menopausal
排除标准
- •Any clinically significant abnormalities in laboratory test results deemed clinically significant by the Investigator.
- •History of non-febrile seizures
- •History of a suicide attempt in the past 12 months or being seen by the Investigator as having significant risk of suicide
- •Positive pregnancy test at Screening or Day-1
- •Active or prior hepatitis B infection or positive test for HIV or Hepatitis C
- •History of lactose intolerance
- •History of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy that is not well managed and stable.as determined by the Investigator.
- •Hospital admission or major surgery within 60 days prior to Screening
研究者
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