NCT02555085终止1 期
Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in antibody titers of vaccine immunization for diphtheria
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers. The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of <1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study.
- •Must have a body mass index between 18 and 30 kg/m2, inclusive.
- •Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
排除标准
- •History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- •History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- •Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS).
- •History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.
- •History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test
- •Personal history of thromboembolic events
- •Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days).
- •Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months
- •Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months
- •Blood donation (1 unit or more) within 3 months prior to randomization.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
结局指标
主要结局
Change in antibody titers of vaccine immunization for diphtheria
时间窗: Up to week 12
Number of participants with clinically significant Vital sign abnormalities
时间窗: Up to week 12
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
时间窗: Up to week 12
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to week 12
Number of participants with clinically significant physical examination abnormalities
时间窗: Up to week 12
Change in antibody titers of vaccine immunization for tetanus
时间窗: Up to week 12
Number of participants with clinically significant laboratory assessment abnormalities
时间窗: Up to week 12
Change in antibody titers of vaccine immunization for pneumococcus
时间窗: Up to week 12
次要结局
- PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)(Up to week 12)
- PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)(Up to week 12)
- PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)(Up to week 12)
- Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063(Up to 12 weeks)
- PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)(Up to week 12)
- PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)(Up to week 12)
- PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)(Up to week 12)
- PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)(Up to week 12)
- PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)(Up to week 12)
- PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)(Up to week 12)
- Number of participants with positive serum anti-BIIB063 antibodies(Up to week 12)
研究者
研究点 (2)
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