NCT04532294已完成1 期
A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Healthy Subjects
BeiGene1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data
- •Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study
- •Have a medical history of SARS infection
- •Any acute fever disease or infections
- •Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to: diabetes mellitus type I, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BGB-DXP593: Dose Level A
Experimental
Participants will receive BGB-DXP593 10 mg/kg on Day 1
干预措施: BGB DXP593 (Drug)
BGB-DXP593: Dose Level B
Experimental
Participants will receive BGB-DXP593 30 mg/kg on Day 1
干预措施: BGB DXP593 (Drug)
Placebo
Experimental
Placebo to match (PTM) BGB-DXP593 on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: From the day of study drug administration until 30 days after dose (up to approximately 160 days)
A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug
次要结局
- Volume of Distribution (Vz) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- Clearance (CL) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29)
- Terminal Half Life (t1/2) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)(Up to approximately160 days)
- Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms(Up to approximately 160 days)
- AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- Number of Participants With Clinically Relevant Changes in Laboratory Parameters(Up to approximately 160 days)
- Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
- Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593(Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days))
研究者
研究点 (1)
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