ACTRN12620001051932已完成1 期
GS-US-496-5619: A Phase 1 Study in Healthy Volunteers to Evaluate the Single DosePharmacokinetics, Safety, and Tolerability of GS-3583.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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 45 Years（—）
- 性别
- All
入选标准
- •Have a body mass index (BMI) of 19.0 and 30.0 kg per m2 at screening
- •- Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued
- •90 days prior to screening
- •- Must be willing and able to comply with all study requirements
- •- Must, in the opinion of the investigator, be in good health based upon medical history and
- •physical examination, including vital signs
排除标准
- •- Breastfeeding female
- •- Have received any study drug within 30 days prior to study dosing
- •- Have any serious or active medical or psychiatric illness (including depression) that, in the
- •opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- •with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary
- •(including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal
- •(including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease),
- •immunodeficiency disorders, active infection, or malignancy that are clinically significant or
- •requiring treatment
- •- Have a family history of autoimmune diseases such as rheumatoid arthritis, inflammatory
- •bowel disease, etc
研究者
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