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

Syneos Health

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Omalizumab Prefilled Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT05053334

BP11-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 165 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.
3. 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.
4. 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.
5. 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

1. Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.
2. 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.
3. 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.
4. Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
5. Difficulty in blood sampling or difficulty in accessibility of veins.
6. 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]).
7. 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.
8. Subjects with positive drug test at screening or admission.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups

BP11 (Proposed biosimilar)

Experimental group

Description:

Subcutaneous injection of Omalizumab developed by CuraTeQ.

Treatment:

Drug: Omalizumab Prefilled Syringe

US-Xolair

Active Comparator group

Description:

Subcutaneous injection of Omalizumab licensed for use in USA

Treatment:

Drug: Omalizumab Prefilled Syringe

EU-Xolair

Active Comparator group

Description:

Subcutaneous injection of Omalizumab approved for use in Europe.

Treatment:

Drug: Omalizumab Prefilled Syringe