An Open-Label, Randomized, Parallel-Group, Single-Dose Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Seroconversion response
研究概览
简要总结
The purpose of the study is to evaluate whether administration of bimekizumab has an effect on the expected production of antibody titers to the influenza vaccine.
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
- 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
- •Subject is male or female aged ≥18 years and ≤55 years at the Screening Visit
- •Subject must have a blood test with at least two influenza antibody titers ≤1/10 at the Screening Visit and have not developed any flu-like illness 2 weeks before the start of the study
- •Female subjects of childbearing potential must not be lactating and have a negative serum pregnancy test at the Screening Visit, which is confirmed to be negative by urine testing prior to administration of bimekizumab. Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 20 weeks after their last dose of the investigational medicinal product (IMP)
- •Subject has a body weight of ≥45 kg and body mass index (BMI) between 18 and 32 kg/m2 (inclusive), at the Screening Visit
排除标准
- •Subject has a known hypersensitivity to any excipients of bimekizumab
- •Subject has a history of hypersensitivity to the influenza vaccine
- •Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study
- •Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
- •Male subjects who are planning a partner pregnancy during the study
- •Subjects receiving vaccination of any kind within the 52 weeks prior to the Screening Visit or the influenza vaccination within 2 years prior to the Screening Visit. Live vaccines are not allowed during the study or for 20 weeks after the last dose of investigational medicinal product (IMP)
- •Subject has a current or past history of gastrointestinal ulceration or other gastrointestinal disease, such as inflammatory bowel disease
- •Subject has an active infection
- •Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection or human T-cell lymphotropic virus type-1 (HTLV-1)
研究组 & 干预措施
Bimekizumab
Subjects randomized to this arm will receive a single dose bimekizumab followed by inactivated influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Seroconversion response
时间窗: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
A subject is considered as a seroconversion responder if the following is true: subject has either a pre-vaccination HI titer ≤1/10 and a 4-week post-vaccination HI titer ≥1/40 or a pre-vaccination HI titer \>1/10 and a ≥4fold increase in HI titer 4 weeks after vaccination in at least 2 out of 4 serotypes.
Incidence of Adverse Events (AE) from Baseline to Safety Follow Up
时间窗: From Baseline to Safety Follow Up (up to Day 140)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Plasma concentration of bimekizumab (BKZ)
时间窗: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Bimekizumab plasma concentrations by scheduled sampling time.
次要结局
- Influenza antibody geometric mean titers (GMT)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Area under the BKZ plasma concentration-time curve over the first 14 days AUC(0-14)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14))
- Area under the BKZ plasma concentration-time curve over the first 28 days AUC(0-28)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28))
- Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Maximum observed BKZ plasma drug concentration (Cmax)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Apparent terminal half-life (t1/2)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))