A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
研究概览
简要总结
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
详细描述
This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •males and non-pregnant, non-lactating females
- •BMI 19.0-32.0
- •willing to abide by contraceptive requirements
- •normal vitals
- •willing to abide by study procedures and restrictions
排除标准
- •clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
- •abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
- •known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
- •current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
- •use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
- •Recent or current history of alcohol or drug abuse
- •Regular use of tobacco or nicotine products
- •Positive serology for HBV, HCV, or HIV
- •history of severe adverse reaction to or known sensitivity to any drug
- •pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded
研究组 & 干预措施
placebo
Placebo IV infusion
干预措施: placebo (Drug)
Galidesivir
Galidesivir IV infusion
干预措施: galidesivir (Drug)
结局指标
主要结局
Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
时间窗: AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.
Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).
次要结局
- Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)(Plasma PK parameters are based on sampling over a 21 day period)
- Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)(Plasma PK parameters are based on sampling over a 21 day period)
- Galidesivir Renal Clearance(Urine PK parameters are based on sampling over a 96 hour period.)