NCT02833142已完成1 期
A Randomized, Blinded, Parallel-Group, Phase 1 Study of Pharmacokinetics, Safety and Tolerability of Single Intravenous Doses of BIIB033 (Opicinumab ) Produced by 2 Manufacturing Processes, in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)
研究概览
简要总结
The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- •- Must have a body mass index of 18 to 32 kg/m2, inclusive.
- •- All male participants and all female participants of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for 6 months after being dosed with study treatment. Male participants must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. Male participants must also be willing to refrain from sperm donation for at least 6 months after dosing with study treatment.
- •- Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
排除标准
- •- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease, as determined by the Investigator.
- •- History of or ongoing malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Day -1).
- •- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within the 3 months prior to Day -
- •- Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -
- •- History of severe allergic or anaphylactic reactions, or history of any allergic reaction that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- •- Prior exposure to BIIB
- •- Female participants who are breastfeeding or pregnant at Screening or Day -1, or plan to become pregnant during the study or during the 6 months following study drug administration.
- •- History of, or positive test result at Screening for, human immunodeficiency virus.
- •- History of, or positive test result at Screening for, hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BIIB033-A
Experimental
Staggered single dosing schema
干预措施: BIIB033 (opicinumab) (Drug)
BIIB033-B
Experimental
Staggered single dosing schema
干预措施: BIIB033 (opicinumab) (Drug)
结局指标
主要结局
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)
时间窗: Day 85
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
时间窗: Up to Day 89
PK parameter of BIIB033: Maximum observed concentration (Cmax)
时间窗: Up to Day 89
次要结局
- Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 17 weeks)
- Number of participants with clinically significant laboratory parameters(Up to 17 weeks)
- Number of participants with clinically significant vital sign abnormalities(Up to 17 weeks)
- Number of participants with clinically significant electrocardiograms (ECGs) abnormalities(Up to 17 weeks)
- Number of participants with clinically significant physical examination abnormalities(Up to 17 weeks)
- PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)(Up to Day 89)
- PK parameter of BIIB033: Terminal elimination half-life (t1/2)(Up to Day 89)
- PK parameter of BIIB033: Volume of distribution at steady state (Vss)(Up to Day 89)
- PK parameter of BIIB033: Clearance (CL)(Up to Day 89)
- Number of participants with presence of anti-BIIB033 antibodies(Pre-dose, Day 22 and Day 85)
研究者
研究点 (1)
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