A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult 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
- Number of adverse events as a measure of safety and tolerability
研究概览
简要总结
In this study, the investigators will evaluate the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.
详细描述
Investigators will evaluate in a single ascending dose (SAD) and multiple ascending dose (MAD) fashion, the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years
- •Male or female
- •Medically healthy, as defined by the absence of clinically significant screening results (e.g. laboratory profile, medical history, electrocardiogram (ECG), physical examination)
- •BMI 18-35 kg/m2
- •Voluntary consent to participate in the study
- •No evidence of Lower Extremity Deep Vein Thrombosis (LE DVT) at baseline by ultrasound
排除标准
- •Use of any prescription, investigational, herbal, supplemental, or over the counter medications including aspirin within 14 days (for the SAD phase) and 7 days (for the MAD phase) prior to day 1 or unwilling/unable to refrain from the use of these medications on days 1-8 for the SAD phase and days 1-12 of the MAD phase of the study
- •Previous administration of GMI-1271
- •Positive drug testing at screening and baseline or positive alcohol testing at baseline or unwilling/unable to refrain from the use of drugs or alcohol on days 1-8 for the SAD phase and days 1-12 for the MAD phase of the study
- •Pregnant or breastfeeding
- •Unwilling or unable to use contraception during the time of participation in the trial and 14 days afterwards (sexual abstinence is permissible)
- •Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening
- •Hypersensitivity or allergic reaction to compounds related to GMI-1271
- •Use of moderate caffeine (≥ 300 mg/day) within 48 hours prior to dosing (day 1)
- •History of bleeding disorder
- •Any liver function test > 1.5 times upper limit of normal or renal insufficiency with creatinine clearance < 30 ml/min.
研究组 & 干预措施
Placebo
IV Placebo
干预措施: Placebo (Drug)
Enoxaparin Sodium (Lovenox®)
SC Lovenox®
干预措施: Enoxaparin Sodium (Lovenox®) (Drug)
GMI-1271
IV GMI-1271
干预措施: GMI-1271 (Drug)
结局指标
主要结局
Number of adverse events as a measure of safety and tolerability
时间窗: 14-19 days
Adverse Event data review
Type of adverse events as a measure of safety and tolerability
时间窗: 14-19 days
Adverse Event data review
Severity of adverse events as a measure of safety and tolerability
时间窗: 14-19 days
Adverse Event data review
Review of lab results as a measure of Pharmacokinetics
时间窗: 3-5 days
AUC (mg/mL)
次要结局
- Incidence of bleeding(14-19 days)