A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants
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 treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
研究概览
简要总结
This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.
The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is present in the blood of study participants at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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
- •Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
- •NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
研究组 & 干预措施
IV Cohort 1 Low Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV Cohort 1 Low Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
IV Cohort 2 Mid Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV Cohort 2 Mid Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
IV Cohort 3 High Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV Cohort 3 High Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
IV Cohort 4 Higher Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV Cohort 4 Higher Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
IV Cohort 5 Highest Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV Cohort 5 Highest Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
SC Cohort 1 Low Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
SC Cohort 1 Low Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
SC Cohort 2 High Dose
Randomized as described in the protocol
干预措施: REGN13335 (Drug)
SC Cohort 2 High Dose
Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
IV or SC Optional Cohort
≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol
干预措施: REGN13335 (Drug)
IV or SC Optional Cohort
≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
时间窗: Baseline to day 113
Severity of TEAE's through the EOS visit
时间窗: Baseline to day 113
次要结局
- Concentrations of functional REGN13335 in plasma through the EOS visit(Baseline to day 113)
- Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time(Baseline to day 113)
- Titer of ADA to single doses of REGN13335 over time(Baseline to day 113)