A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants
The secondary objectives of the study are to:
- Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
- Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490
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
- •Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
- •Is in good health based on laboratory safety testing obtained at the screening visit
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide informed consent signed by study participant
排除标准
- •History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- •Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- •Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
- •Hospitalization (>24 hours) for any reason within 30 days of the screening visit
- •Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit
- •Note: Other protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
IV Cohort 1
Single intravenous (IV) dose 1 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
IV Cohort 2
Single IV dose 2 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
IV Cohort 4
Single IV dose 4 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
IV Cohort 1
Single intravenous (IV) dose 1 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
IV Cohort 2
Single IV dose 2 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
IV Cohort 3
Single IV dose 3 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
IV Cohort 3
Single IV dose 3 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
IV Cohort 4
Single IV dose 4 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
IV Cohort 5
Single IV dose 5 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
IV Cohort 5
Single IV dose 5 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
SC Cohort 1
Single subcutaneous (SC) dose 1 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
SC Cohort 1
Single subcutaneous (SC) dose 1 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
SC Cohort 2
Single SC dose 2 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
SC Cohort 2
Single SC dose 2 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
SC Cohort 3
Single SC dose 2 of REGN6490 or matching placebo
干预措施: REGN6490 (Drug)
SC Cohort 3
Single SC dose 2 of REGN6490 or matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Week 16
TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)
次要结局
- Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)(Up to Week 16)
- Serum Concentration of REGN6490 over time(Up to Week 16)