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

NCT05053334 | Completed Phase 1 FDA Drug

• 1 other identifier: BP11-101
• Study Type: interventional
• Target: 165
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair

  Upto 127 Days

• To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair

  Upto 127 Days

• 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

• To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair

  Upto 127 Days

Study Arms (3)

BP11 (Proposed biosimilar)

EXPERIMENTAL

Subcutaneous injection of Omalizumab developed by CuraTeQ.

Drug: Omalizumab Prefilled Syringe

US-Xolair

ACTIVE COMPARATOR

Subcutaneous injection of Omalizumab licensed for use in USA

Drug: Omalizumab Prefilled Syringe

EU-Xolair

ACTIVE COMPARATOR

Subcutaneous injection of Omalizumab approved for use in Europe.

Drug: Omalizumab Prefilled Syringe

Interventions

Omalizumab Prefilled Syringe DRUG

150mg/ml of Omalizumab prefilled syringe

BP11 (Proposed biosimilar); EU-Xolair; US-Xolair

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneos Health: lead
• CuraTeQ Biologics Private Ltd.: collaborator

Study Sites (3)

Q-Pharm Pty Ltd

Herston, Queens Land, 4006, Australia

Location

Auckland Clinical Studies Ltd (NZCR OpCo Limited)

Grafton, Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)

Christchurch, 8011, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 22, 2021
• Study Start: February 16, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: June 5, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); AU (1)