A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of laboratory abnormalities
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.
The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing
- •Participant 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 or legally acceptable representative
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease
- •Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation
- •Hospitalization for any reason within 60 days of the screening visit
- •Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening
- •History of drug or alcohol abuse within a year prior to the screening visit
- •Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot
- •Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years
- •Note: Other protocol Inclusion/Exclusion Criteria apply
研究组 & 干预措施
Cohort 1
Cohort 1 will receive a single IV dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 1
Cohort 1 will receive a single IV dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 2
Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 2
Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 3
Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 3
Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 4
Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 4
Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 5
Cohort 5 will receive a single SC dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 5
Cohort 5 will receive a single SC dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 6
Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 6
Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
Cohort 7
Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: REGN5069 (Drug)
Cohort 7
Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of laboratory abnormalities
时间窗: From baseline up to week 36
As measured by chemistry, hematology and urinalysis
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: From baseline up to week 36
Incidence of vital signs abnormalties
时间窗: From baseline up to week 36
As measured by heart rate, blood pressure, body temperature and respiratory rate
Incidence of standard 12-lead electrocardiogram (ECG) abnormalties
时间窗: From baseline up to week 36
As measured by heart rate, PR, complex of Q, R, and S waves \[QRS\], QT-intervals, and QTc
次要结局
- Concentration of REGN5069 in serum over time(From baseline up to week 36)
- Incidence of anti-drug antibody (ADA)(From baseline up to week 36)