An Open-Label, Multicenter, Randomized, Parallel-Group, 3-Arm, Single-Dose Bioequivalence Study of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-Injector in Adult Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up
研究概览
简要总结
The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.
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
- •Participant is male or female aged >=18 years and <=55 years at Screening Visit
- •Participant must be in good health (physically and mentally) as determined by the Investigator based on medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests during the Screening Period
- •Participant has a body mass index (BMI) of 18-32 kg/m2 and a minimum body weight of 50 kg for male participants and 45 kg for female participants, and a maximum body weight of 100 kg for all participants
- •Participant is willing to abstain from alcohol-, tobacco-, and caffeine-containing products for 48 h prior to admission into the clinic and during the entire in-clinic stay
排除标准
- •Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
- •Participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening Visit
- •Participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •Female participant 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
- •Participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to Screening visit (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of the IMP
- •Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
- •Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
研究组 & 干预措施
Bimekizumab-SS
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.
干预措施: Bimekizumab (Drug)
Bimekizumab-AI
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.
干预措施: Bimekizumab (Drug)
Bimekizumab-TN
Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up
时间窗: From Baseline to Safety Follow Up (up to Day 140)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Percentage of subjects with at least one Adverse Event (AE) from first bimekizumab (BKZ) dose up 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.
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)
时间窗: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
时间窗: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule.
Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
时间窗: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/lambdaz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.
次要结局
- Percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (%AUCex)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Apparent terminal elimination rate constant (lambdaz)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Total body plasma clearance for BKZ (CL/F)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Volume of distribution for BKZ (Vz/F)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Time to last quantifiable BKZ plasma concentration (tmin)(From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140))
- Incidence of Anti-drug-antibodies (ADABs)(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))
- 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))