NCT03722329已完成1 期
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- AUCinf
研究概览
简要总结
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Have a body weight between 70-95 kg and a body mass index between 20.0-29.9 kg/m²
- •Have systolic blood pressure (SBP) ≤ 140 and ≥ 90 mmHg, diastolic blood pressure (DBP) ≤ 95 and ≥ 45 mmHg, and pulse rate ≥ 40 and ≤ 100 beats per minute or assessed as not clinically significant
- •Have physical examination and 12-lead ECG results without clinically significant finding at Screening and Day -1 visits
- •Non-smoker or smoker whose daily smoking does not exceed 10 cigarettes, 3 cigars, or 3 pipes for at least 30 days prior to Screening visit. Subjects should agree to abstain from smoking while resident at the clinical study site.
- •Willing to receive vaccination against N. meningitidis at least 14 days prior to IP administration
- •Male subjects must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception unless their partner is infertile from the time of IP administration until 5 months after IP administration
- •Must be willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations
- •Have competence in speaking, writing and comprehending the local language where the study is conducted
排除标准
- •Have a history/presence of clinically significant atopic allergy, allergic/hypersensitive reactions, or known or suspected clinically relevant drug hypersensitivity to eculizumab or its excipients
- •Contraindication for IP or non-IP to be used in the study
- •History of N. meningitidis infection
- •Known or suspected hereditary or acquired complement deficiency
- •Clinically significant active infection within 28 days before IP administration
- •Any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory condition
- •Have previously been exposed to eculizumab (Soliris and its biosimilar)
- •Previous treatment with a monoclonal antibody or fusion protein within 9 months prior to IP administration and/or have an evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein
- •Have previously been exposed to an immunosuppressive agent or biological agent (any other than a monoclonal antibody or fusion protein) within 120 days prior to IP administration
- •Any of the following abnormal laboratory values at Screening and Day -1 visits:
- •Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 × ULN
- •Serum C-reactive protein ≥ 10 mg/L
- •Serum creatinine > 1.5 × ULN
- •Whole blood cell count < 3000/mm3, absolute lymphocyte count < 800/mm3, and/or absolute neutrophil count ≤ 1500/mm3
- •Any other laboratory abnormalities assessed as clinically significant by the Investigator
- •Positive test result for hepatitis B surface antigen and/or hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus at Screening
- •Surgery within 90 days prior to IP administration, and/or operation during study period
- •Average intake of alcoholic beverages of more than 21 units/week for males and 14 units/week for females
- •Drug abuse or a positive urinary drug screening result
- •Have any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study, within 14 days prior to IP administration
- •Donated >100 mL blood or plasma within 28 days prior to IP administration
- •Subject directly involved in the conduct of the clinical study
- •Vulnerable subjects
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
SB12
Experimental
SB12 (proposed eculizumab biosimilar)
干预措施: Eculizumab (Drug)
EU Soliris
Active Comparator
EU sourced Soliris (eculizumab)
干预措施: Eculizumab (Drug)
US Soliris
Active Comparator
US sourced Soliris (eculizumab)
干预措施: Eculizumab (Drug)
结局指标
主要结局
AUCinf
时间窗: Day 1 to Day 64
Area under the concentration-time curve from time zero to infinity
次要结局
- Incidence of ADA(Day 1 to Day 64)
- Vz(Day 1 to Day 64)
- Clearance(Day 1 to Day 64)
- %AUCextrap(Day 1 to Day 64)
- Incidence of Serious Adverse Events(Day 1 to Day 64)
- T1/2(Day 1 to Day 64)
- AUClast(Day 1 to Day 64)
- Cmax(Day 1 to Day 64)
- Tmax(Day 1 to Day 64)
- λz(Day 1 to Day 64)
- Incidence of Treatment-Emergent Adverse Events(Day 1 to Day 64)
- Incidence NAb(Day 1 to Day 64)
研究者
研究点 (1)
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