NCT04728061已完成1 期
A Phase 1a/1b, Randomized, Double-blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124 After Single and Multiple IV Infusion Dosing in Healthy Volunteers
GEn1E Lifesciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年1月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The incidence of adverse events from the start of randomization through the final follow-up visit
研究概览
简要总结
In this early phase clinical research study, the investigational drug will be administered to 64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center. The objectives of the study are to assess what the body does to the investigational drug, what the investigational drug does to the body and also to observe the safety and tolerability of the investigational drug healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy male and female subjects;
- •Between 18 and 55 years of age;
- •Provide a signed EC-approved consent form;
- •Generally healthy, in the opinion of the Investigator;
- •Body Mass Index (BMI) 18 to 30 kg/m^2;
- •Creatinine clearance with in specific parameter;
- •Using method of contraception;
- •Willing and able to comply with protocol requirements for the duration of the study.
排除标准
- •Subjects taking prohibited medication;
- •Subjects with a history or presence of clinically significant medical or psychiatric disease;
- •Subjects who have regularly used nicotine-containing products ;
- •Subjects who have used caffeine-containing products;
- •Subjects who are unable to comply with eating a standardized meal during the study;
- •Subjects with a hospital admission or major surgery within 30 days prior to Screening;
- •Subjects with a plasma donation within 7 days prior to Screening;
- •Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit;
- •Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
- •Subjects who are pregnant or breastfeeding
- •Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
- •Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
研究组 & 干预措施
Single Ascending Dose
Experimental
干预措施: Placebo (Drug)
Single Ascending Dose
Experimental
干预措施: Gen1E-1124 (Drug)
Multiple Ascending Dose
Experimental
干预措施: Gen1E-1124 (Drug)
Multiple Ascending Dose
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of adverse events from the start of randomization through the final follow-up visit
时间窗: Up to 14 days post-dose
次要结局
- Urine levels of GEn1E-1124 and potential metabolites(Through 24 hours post-dose)
- Selected biomarkers measured in whole blood(Up to 24 hours post-dose)
- Plasma levels of GEn1E-1124 and potential metabolites(Through 24 hours post-dose)
- Cytokines measured in whole blood(Up to 24 hours post-dose)
研究者
研究点 (1)
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