NCT05292131已完成1 期
An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 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), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL 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 Period and on admission
- •Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening 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
- •Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.
排除标准
- •Study participant has a known hypersensitivity to any components of the bimekizumab (and/or an investigational device) as stated in this protocol
- •Study participant has an active infection or history of infections as follows:
- •Any active infection (except common cold) within 14 days prior to 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 TB test or evidence of possible TB or latent TB infection at Screening Visit. Refer to Tuberculosis Detection Procedure Guideline for details regarding TB infection status, detection procedures, and the related exclusion criteria
- •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 last dose of the investigational medicinal product (IMP)
- •Study participant has previously participated in this study or a study participant has previously been assigned to bimekuzimab treatment in any other study
- •Exposure to 3 or more new chemical entities within 12 months prior to dosing
- •Current enrollment or past participation within the last 30 days before signing the informed consent form (ICF) in any other clinical study involving an investigational study intervention or any other type of medical research
- •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 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
- •Female study 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
- •Study participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week (1 unit of alcohol is equivalent to 12.5 mL ethanol at room temperature)
- •Study participant tests positive for alcohol or drugs (urine test) at Screening or Day -1
- •Vulnerable study participants (eg, participants kept in detention, protected adults under guardianship or trusteeship, and soldiers or participants committed to an institution by governmental or juridical order), employees of the Sponsor or the contract research organization (CRO) with direct involvement in the proposed study or other studies under the direction of the Investigator or the CRO, as well as family members of the employees or the Investigator
- •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 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
Experimental
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).
干预措施: bimekizumab (Drug)
Reference
Other
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).
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: Baseline (Day 1 predose) at predefined time points (up to Day 140)
AUC is the area under the plasma concentration-time curve from time 0 (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 plasma concentration-time curve from time zero (Day 1 predose) to the last 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 a maximum observed plasma concentration.
次要结局
- 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))
- 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))
- Apparent Terminal Half-life (t1/2)(From Baseline (Day 1 predose) at predefined time points (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))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy VolunteersHepatic ImpairmentNCT01621633Novartis Pharmaceuticals32
已完成
1 期
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female SubjectsHealthyNCT02223832Actelion20
已完成
1 期
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male VolunteersEssential HypertensionNCT00937534Boryung Pharmaceutical Co., Ltd22
已完成
1 期
Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) TabletHealthyNCT01016626Chong Kun Dang Pharmaceutical28
已完成
1 期
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy SubjectsChronic Myeloid LeukemiaGastrointestinal Stromal TumorsNCT01270984Chong Kun Dang Pharmaceutical30