NCT04491838已完成1 期
A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A
研究概览
简要总结
The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Process B)
The secondary objectives of the study are:
- Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes
- Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 weight of 55 kg to 100 kg and a body mass index between 18 kg/m2 and 30 kg/m2 inclusive at the screening visit
- •Judged to be in good health based on medical history, physical examination, vital signs measurements, and ECG performed at screening and/or prior to administration of initial dose of study drug
- •Is in good health based on laboratory safety testing obtained at the screening visit. NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
- •Willing to undergo vaccination against N meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
- •Must have two negative COVID-19 tests within 7 days prior to study drug administration as defined 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
- •Hospitalization (>24 h) for any reason within 90 days of the screening visit
- •Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; and/or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
- •Is positive for HIV, hepatitis B, or hepatitis C antibody as defined in the protocol
- •Known or suspected COVID-19 disease
- •History of tuberculosis, systemic fungal diseases, or meningococcal infection
- •Known allergy or intolerance to penicillin class antibiotics or macrolides; any contraindication to azrithromycin per local prescribing information
- •Note: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
Process A
Experimental
Randomized 1:1
干预措施: Pozelimab (Drug)
Process B
Experimental
Randomized 1:1
干预措施: Pozelimab (Drug)
结局指标
主要结局
Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A
时间窗: Up to 16 weeks
Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B
时间窗: Up to 16 weeks
Assess peak concentration (Cmax) PK profile of pozelimabin in Process A
时间窗: Up to 16 weeks
Assess peak concentration (Cmax) PK profile of pozelimab in Process B
时间窗: Up to 16 weeks
次要结局
- Incidence of treatment emergent adverse events (TEAEs)(Up to 16 weeks)
- Incidence of anti-drug antibodies (ADA) to pozelimab over time(Up to 16 weeks)
研究者
研究点 (1)
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