An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
研究概览
简要总结
The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
- •Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Visit and on admission
- •Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening Visit
排除标准
- •Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- •Study participant has a known hypersensitivity to any excipients of bimekizumab (and/or an investigational device) as stated in this protocol
- •Study participant has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms, and/or requires therapy to maintain stable status
- •Study participant has an active infection or history of infections as follows:
- •Any active infection (except common cold) within 14 days prior to the Screening Visit
- •A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
- •A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, cryptococcosis) or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster)
- •Study participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at the Screening Visit
- •Study participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Study participants who have evidence of, or tested positive for hepatitis B or hepatitis C are excluded
- •Study participant has 12-lead ECG with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula [QTcF] >450 ms, bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or on Day -1
- •Study participant has active neoplastic disease or history of neoplastic disease within 5 years of the 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)
- •Study participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to the 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 dose of the investigational medicinal product (IMP)
- •Study participant has previously participated in this study or the study participant has previously been assigned to treatment in a study of the medication under investigation in this study
- •Study participant has participated in another study of an IMP (and/or an investigational device) within the previous 90 days or 5 half-lives, whichever is longer, prior to IMP administration
- •Study participant has made a blood donation of a blood loss of more than 400 mL of blood or blood products within 90 days prior to admission (Day -1) or plans to donate blood during the study
- •Study participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in real-time reverse transcriptase polymerase chain reaction (RT-PCR) on the admission sample
- •Study participant has clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19), eg fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission
- •Study participant who had severe course of COVID-19 (ie, hospitalization, extracorporal membrane oxygenation, mechanically ventilated)
研究组 & 干预措施
Test 1
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with bimekizumab-safety syringe-2 mL presentation (test 1).
干预措施: Bimekizumab (Drug)
Reference 1
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-safety syringe-1 mL presentation (reference 1).
干预措施: Bimekizumab (Drug)
Test 2
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-2 mL presentation (test 2).
干预措施: Bimekizumab (Drug)
Reference 2
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-1 mL (reference 2).
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
时间窗: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
AUC is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to infinity.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
时间窗: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)
AUC0-t is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last observed quantifiable concentration.
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
时间窗: From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Cmax is the maximum observed plasma concentration.
次要结局
- Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up(From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140))
- Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up(From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140))
- Apparent Terminal Half-life (t1/2)(From Baseline (Day 1 predose) at predefined time points (up to Day 140))
- Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)(From Baseline (Day 1 predose) at predefined time points (up to Day 140))