A Randomized Phase I, Double-Blinded, Parallel Comparative Assessment of PK, PD, Safety, and Immunogenicity of BP11 Versus US-Licensed Xolair® and EU Approved-Xolair® Following a Single 150 mg Dose SC Administration in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
研究概览
简要总结
A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.
详细描述
The study will be conducted at 2 sites in New Zealand and 1 site in Australia.
A total of 165 healthy male subjects (55 subjects per arm) who meet the required entry criteria will be randomly assigned to one of 3 treatment groups in a 1:1:1 ratio to receive a single SC injection of either BP11, EU-Xolair, or US-Xolair.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator.
- •Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.
- •Subjects who are considered healthy as determined by clinically acceptable findings of hematology, clinical chemistry, coagulation profile, urinalysis, and 12-lead ECG as per investigator's discretion.
- •Subject must agree to use a highly effective contraception as detailed in Appendix 1(Section 13.1) during the study period (starting from screening visit) and until 9 months after administration of BP11, Xolair® -EU or Xolair® -US by agreeing to use (with their female partner if she is of childbearing potential) 2 acceptable forms of contraception.
- •Subjects must refrain from donating sperm or fathering a child during the study period (starting from screening visit) and until 9 months after administration of BP11, Xolair®-EU or Xolair®-US administration by agreeing to use (with their female partner if she is of childbearing potential) 2 acceptable forms of contraception.
排除标准
- •Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.
- •History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
- •Abnormal and clinically relevant (in the opinion of the Investigator) vital signs, ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
- •Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- •Difficulty in blood sampling or difficulty in accessibility of veins.
- •History of significant alcohol abuse within 1 years prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- •History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
- •Subjects with positive drug test at screening or admission.
研究组 & 干预措施
BP11 (Proposed biosimilar)
Subcutaneous injection of Omalizumab developed by CuraTeQ.
干预措施: Omalizumab Prefilled Syringe (Drug)
US-Xolair
Subcutaneous injection of Omalizumab licensed for use in USA
干预措施: Omalizumab Prefilled Syringe (Drug)
EU-Xolair
Subcutaneous injection of Omalizumab approved for use in Europe.
干预措施: Omalizumab Prefilled Syringe (Drug)
结局指标
主要结局
To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
时间窗: Upto 127 Days
AUC0-inf will be evaluated
To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
时间窗: Upto 127 Days
Cmax will be evaluated
次要结局
- Safety & tolerability of BP11 with US-Xolair and EU-Xolair(Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.)
- To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair(Upto 127 Days)
- To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair(Upto 127 Days)