Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
US-Xolair	Omalizumab Prefilled Syringe	Subcutaneous injection of Omalizumab licensed for use in USA
EU-Xolair	Omalizumab Prefilled Syringe	Subcutaneous injection of Omalizumab approved for use in Europe.
BP11 (Proposed biosimilar)	Omalizumab Prefilled Syringe	Subcutaneous injection of Omalizumab developed by CuraTeQ.

Primary Outcome Measures

Name	Time	Method
To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair	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	Upto 127 Days	Cmax will be evaluated

Secondary Outcome Measures

Name	Time	Method
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.	Assessment of injection site reaction
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair	Upto 127 Days	Tmax, T½
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair	Upto 127 Days	Total IgE levels will be assessed

Recruitment & Eligibility