NCT07526116招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans.
The purpose of this study is to learn:
- What side effects may happen when REGN22044 is taken
- How much of REGN22044 is in the blood at different times
- Whether the body makes antibodies against REGN22044 (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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Is judged by the investigator to be in good health as described in the protocol
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator
- •Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol
- •Participants with fever (>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment
- •Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
- •Note: Other protocol defined Inclusion/ Exclusion criteria apply.
研究组 & 干预措施
Subcutaneous (SC) Cohorts
Experimental
干预措施: Placebo (Drug)
Subcutaneous (SC) Cohorts
Experimental
干预措施: REGN22044 (Drug)
Intravenous (IV) Cohorts
Experimental
干预措施: REGN22044 (Drug)
Intravenous (IV) Cohorts
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 18 weeks
Severity of TEAEs
时间窗: Up to 18 weeks
次要结局
- Concentration of REGN22044 in serum(Up to 18 weeks)
研究者
研究点 (1)
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