NL-OMON35061已完成不适用
A Phase I/IIa Study Assessing Single and Multiple Doses of study drug in Healthy and Genotype 1 HCV-Infected Subjects - SAD/FE/MAD study in healthy subjects and HCV patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 18-65 years of age, inclusive (or the legal age of consent per local regulations).
- •2.Body Mass Index (BMI) 18-35 kg/m2
- •3.Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control from first dose through at least 90 days after the last dose of the study drug.
- •4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
- •5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study.
- •6.Pulse * 40 BPM, systolic blood pressure * 95 mmHg and QTcF interval * 450 ms at screening and Day -1.
- •7. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
- •8.Subject has provided written informed consent to participate in the study.
排除标准
- •1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
研究者
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