A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of safety and tolerability
研究概览
简要总结
Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy adult participants.
详细描述
This is a randomized, double blind, placebo-controlled, dose escalation, first-in-human, Phase I clinical trial to assess the safety, tolerability, PK and immunogenicity of IDB-011 in healthy volunteers aged 18-64. IDB-011 is comprised of IDB-774 and IDB-898, which will be administered as separate, consecutive intramuscular injections.
Volunteers will be recruited into sequential dosing cohorts. Within each cohort, eligible volunteers will be randomly allocated (6:2) to receive either IDB-011 or placebo (0.9% normal saline). A sentinel dosing scheme will be employed for the first 2 volunteers in each dosing cohort.
Volunteers will stay in a clinical research unit for up to 4 consecutive days and be followed for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female
- •Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m^2, inclusively
- •Female participants must not be pregnant, breastfeeding or intend to become pregnant through 1 year post-administration
- •Male subjects must agree to not cause pregnancy or donate sperm for 1 year post-administration
- •Non-smoker
- •Agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior to administration and during the confinement period
- •Agree to not donate blood or plasma during study participation
- •Agree not to travel to Rift Valley fever virus (RVFV) endemic areas during participation
排除标准
- •Known history of RVFV infection
- •Previous receipt of RVFV vaccine
- •Illness with fever within 5 days prior to administration
- •History of malignancy within prior 5 years
- •History of significant cardiovascular, pulmonary, gastrointestinal, liver, kidney, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic disease
- •History of hypersensitivity reaction
- •History or clinical evidence of alcohol abuse
- •Human immunodeficiency virus (HIV) positive
- •Hepatitis C virus positive
- •Hepatitis B virus positive
- •Received immunoglobulin or antibody product within 6 months of administration
- •Vaccine within 28 days of administration
- •Received investigational agent within 3 months or < 5 half-lives (whichever is longer) prior to administration
- •Donation of plasma, 1 unit or > 500 mL blood donation in 56 days prior to administration
研究组 & 干预措施
Experimental: IDB-011 Cohort 1
IDB-011 dose level 1
干预措施: IDB-011 dose level 1 (Drug)
Experimental: IDB-011 Cohort 2
IDB-011 dose level 2
干预措施: IDB-011 dose level 2 (Drug)
Experimental: IDB-011 Cohort 3
IDB-011 dose level 3
干预措施: IDB-011 dose level 3 (Drug)
Experimental: IDB-011 Cohort 4
IDB-011 dose level 4
干预措施: IDB-011 dose level 4 (Drug)
Experimental: IDB-011 Cohort 5
IDB-011 dose level 5
干预措施: IDB-011 dose level 5 (Drug)
Comparator: Placebo
Normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Evaluation of safety and tolerability
时间窗: Through 1 year from administration
Safety to be measured via occurrence and severity of adverse events
次要结局
- Characterize pharmacokinetic profile(Through 1 year from administration)
- Evaluate immunogenicity(Through 1 year from administration)