ACTRN12624000642583尚未招募1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STC-004 in Healthy Adults
SiteOne Therapeutics0 个研究点目标入组 76 人开始时间: 2024年5月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
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 55 Years（—）
- 性别
- All
入选标准
- •Healthy male and/or female, 18 to 55 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
- •- Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests
排除标准
- •- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by an Investigator to be clinically relevant.
- •- History of drug or alcohol abuse
- •- Use of an prescription medications or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 14 days or 5 half-lives (whichever is longer)
- •- Blood donation of approximately 500 mL within 56 prior to Screening
- •- Any condition or prior therapy, eg. seizures or head trauma, that may lead to CNS effects during the study
研究者
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