ACTRN12622001349730终止1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UA021 in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
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 65 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 45 kg at the screening visit.
- •Adhere to effective double barrier contraception or are proven post-menopausal
排除标准
- •A history of stomach or intestinal surgery or resection that would potentially alter
- •the absorption and/or excretion of orally administered drugs taken.
- •Presence of a malabsorption syndrome e.g., Crohn’s Disease
- •Any clinically significant abnormalities in laboratory test results deemed clinically
- •significant by the Investigator.
- •History of immunological disorders, auto-immune disorders, acquired or congenital
- •immune deficiency or acute infection within 3 months before the start of the screening
- •Active or prior hepatitis B infection or positive test for HIV or Hepatitis C
- •Poorly controlled hypertension or diabetes mellitus
- •Major surgery within 6 months of study entry.
研究者
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