NCT04669262已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Subjects
BeiGene1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年12月9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
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants
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
- Double (Participant, 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
- •Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- •Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
- •Negative SARS-CoV-2 serology test
- •Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)
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 receiving the study drug; or interfering with the interpretation of data
- •Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years
- •Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
- •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 type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
- •Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part 1: BGB-DXP604
Experimental
Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo
干预措施: BGB-DXP604 (Drug)
Part 1: BGB-DXP604
Experimental
Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo
干预措施: Placebo (Drug)
Part 2 : BGB-DXP604 + BGB-DXP593
Experimental
Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo
干预措施: BGB-DXP604 (Drug)
Part 2 : BGB-DXP604 + BGB-DXP593
Experimental
Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo
干预措施: BGB-DXP593 (Drug)
Part 2 : BGB-DXP604 + BGB-DXP593
Experimental
Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
时间窗: From the day of study drug administration until 30 days after the dose (approximately day 113 )
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. An SAE is any untoward medical occurrence that, at any dose results in death, or is life threatening, or requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect, or is considered a significant medical AE by the investigator based on medical judgment.
次要结局
- Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29)
- Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29)
- Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Half-life Time (t1/2) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Half-life Time (t1/2) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings(From the day of study drug administration until 30 days after the dose (approximately day 113))
- Maximum Observed Serum Concentration (Cmax) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/End of Study (EOS))
- Maximum Observed Serum Concentration (Cmax) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Clearance (CL) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Clearance (CL) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Volume of Distribution (Vz) of BGB-DXP593(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Volume of Distribution (Vz) of BGB-DXP604(Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS)
- Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593(Pre-dose and Days 15,29,57,85 and 113/EOS visit)
研究者
研究点 (1)
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