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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Omalizumab Prefilled Syringe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP11 (Proposed biosimilar)<br>Subcutaneous injection of Omalizumab developed by CuraTeQ. | Drug: Omalizumab Prefilled Syringe<br>* 150mg/ml of Omalizumab prefilled syringe<br>|
| Active Comparator: US-Xolair<br>Subcutaneous injection of Omalizumab licensed for use in USA | Drug: Omalizumab Prefilled Syringe<br>* 150mg/ml of Omalizumab prefilled syringe<br>|
| Active Comparator: EU-Xolair<br>Subcutaneous injection of Omalizumab approved for use in Europe. | Drug: Omalizumab Prefilled Syringe<br>* 150mg/ml of Omalizumab prefilled syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair | AUC0-inf will be evaluated | Upto 127 Days | 
| To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair | Cmax will be evaluated | Upto 127 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair | AUC0-t | Upto 127 Days | 
| To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair | Vd | Upto 127 Days | 
| To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair | Tmax, T½ | Upto 127 Days | 
| To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair | Free IgE levels will be assessed | Upto 127 Days | 
| To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair | Total IgE levels will be assessed | Upto 127 Days | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Assessment of Vital signs-Blood pressure | Upto 127 Days | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Assessment of Vital signs-Pulse rate | Upto 127 Days | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Assessment of Vital signs-Body temperature | Upto 127 Days | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Assessment of Vital signs-Respiratory rate | Upto 127 Days | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Normal 12 Lead ECG (Ventricular rate) | Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3) | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Normal 12 Lead ECG (PR interval) | Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3) | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Normal 12 Lead ECG (QRS complex) | Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3) | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Normal 12 Lead ECG (QT interval and QT interval corrected for heart rate using Bazett's formula) | Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3) | 
| Safety & tolerability of BP11 with US-Xolair and EU-Xolair | Assessment of injection site reaction | Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours. |