NCT02516904已完成1 期
A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
适应症
干预措施
相关药物
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 subjects with clinically significant adverse events (AEs)
研究概览
简要总结
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
详细描述
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-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
- •Males surgically sterilized or using contraception,
- •No significant findings on physical, ECG, clinical laboratory tests,
- •BMI between 18.5 - 32.0,
- •Must provide informed consent
排除标准
- •Females of child bearing potential,
- •Signs and or symptoms of an acute or chronic illness,
- •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
Experimental
single intravenous infusion ascending dose
干预措施: CD101 IV (Drug)
Placebo
Placebo Comparator
normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with clinically significant adverse events (AEs)
时间窗: Up to 3 weeks
次要结局
- Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)(Up to 3 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
An Ascending Multiple Dose Study of CD101 IV in Healthy SubjectsHealthyNCT02551549Cidara Therapeutics Inc.24
已完成
2 期
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging ExtensionCandidemiaMycosesFungemiaInvasive CandidiasisFungal InfectionNCT02734862Cidara Therapeutics Inc.207
已完成
1 期
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) InfectionChronic Hepatitis CNCT00823862Dynavax Technologies Corporation34
进行中（未招募）
1 期
Dose-Escalation Study of SCD-101 in Sickle Cell DiseaseSickle-Beta Zero ThalassemiaSickle Cell DiseaseNCT02380079Invenux, LLC60
已完成
1 期
A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian ParticipantsCovid19NCT04988152Vir Biotechnology, Inc.48