NCT06262477已完成1 期
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
研究概览
简要总结
The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2), inclusive.
- •Total body weight between 60.0 and 90.0 kg, inclusive.
- •Systolic blood pressure <135 millimeters of mercury (mmHg) or >85 mmHg at Screening, after being supine for at least 5 minutes.
- •No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker.
排除标准
- •History or positive test result at Screening for human immunodeficiency virus (HIV).
- •History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody.
- •Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and total hepatitis B core antibody [anti-HBc]).
- •Serious infection (as determined by the Investigator) within the 6 months prior to Screening.
- •History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
- •History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders.
- •History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions.
- •History of angioedema.
- •A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results.
- •Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.).
- •Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
- •Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BIIB800
Experimental
Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
干预措施: BIIB800 (Drug)
Actemra
Experimental
Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
干预措施: Actemra (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
时间窗: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
时间窗: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab
时间窗: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs)(From the first dose of study drug up to the end of the study (up to Day 57))
- Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Maximum Observed Effect (Emax) of sIL-6R(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Time to Emax (tEmax) of sIL-6R(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Apparent Terminal Half-Life (t1/2) of BIIB800 and Actemra(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- AUE of High Sensitivity C-Reactive Protein (hsCRP)(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Minimum Observed Effect (Emin) of hsCRP(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Time to Emin (tEmin) of hsCRP(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab(Pre-dose on Day 1 and multiple time points post-dose (up to Day 57))
- Number of Participants With Positive Tocilizumab Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Status(Day 1 to Day 57)
- Geometric Mean Titer of Anti-drug Antibodies (ADA)(Pre-dose, Days 15, 29, 57)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular LymphomaLymphoma, FollicularNCT01950273Boehringer Ingelheim95
已完成
1 期
Evaluate Safety, Efficacy and PharmacokineticsMetastatic Breast CancerNCT01084863Celltrion143
进行中（未招募）
3 期
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)Relapsing-remitting Multiple Sclerosis (RRMS)NCT06700343Amgen152
已完成
1 期
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing ProcessesAcute Optic NeuritisMultiple SclerosisNCT02833142Biogen28
招募中
3 期
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)NCT06430866Amgen154