A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety as assessed by the number of subjects with clinically significant adverse events
研究概览
简要总结
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.
详细描述
This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Men must be surgically sterilized or using contraception,
- •No significant findings on physical exam, ECG, clinical laboratory tests,
- •Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
- •Must provide written informed consent
排除标准
- •Females of child bearing potential
- •Signs and or symptoms of acute illness or chronic disease
- •Use of prescription medications within 28 days
- •Use of OTC, supplements, and herbals within 14 days
- •Current smoker
- •Previous participation in a clinical study within 28 days
研究组 & 干预措施
CD101 IV
multiple ascending dose intravenous infusion
干预措施: CD101 IV (Drug)
Placebo
normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as assessed by the number of subjects with clinically significant adverse events
时间窗: Up to 2 weeks following last dose of study drug
Number of subjects with clinically significant adverse events (AEs)
次要结局
- Peak plasma concentration (Cmax)(Up to 2 weeks following last dose of study drug)
- Time to reach peak plasma concentration (Tmax)(Up to 2 weeks following last dose of study drug)
- Area under the concentration time curve (AUC)(Up to 2 weeks following last dose of study drug)
- The volume of plasma cleared of the drug per unit time (CL)(Up to 2 weeks following last dose of study drug)
- Apparent volume in which the drug is distributed (Vz)(Up to 2 weeks following last dose of study drug)
- The rate at which a drug is removed from the body (^z),(Up to 2 weeks following last dose of study drug)
- Terminal half-life (t1/2)(Up to 2 weeks following last dose of study drug)