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

Sponsor
Syneos Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05053334
Collaborator
CuraTeQ Biologics Private Ltd. (Other)
165
2
3
7.5
82.5
11.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omalizumab Prefilled Syringe
Phase 1

Detailed Description

The study will be conducted at 2 sites in New Zealand.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Feb 16, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BP11 (Proposed biosimilar)

Subcutaneous injection of Omalizumab developed by CuraTeQ.

Drug: Omalizumab Prefilled Syringe
150mg/ml of Omalizumab prefilled syringe

Active Comparator: US-Xolair

Subcutaneous injection of Omalizumab licensed for use in USA

Drug: Omalizumab Prefilled Syringe
150mg/ml of Omalizumab prefilled syringe

Active Comparator: EU-Xolair

Subcutaneous injection of Omalizumab approved for use in Europe.

Drug: Omalizumab Prefilled Syringe
150mg/ml of Omalizumab prefilled syringe

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    AUC0-t

  2. To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Vd

  3. To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Tmax, T½

  4. To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Free IgE levels will be assessed

  5. To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Total IgE levels will be assessed

  6. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Assessment of Vital signs-Blood pressure

  7. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Assessment of Vital signs-Pulse rate

  8. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Assessment of Vital signs-Body temperature

  9. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Upto 127 Days]

    Assessment of Vital signs-Respiratory rate

  10. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)]

    Normal 12 Lead ECG (Ventricular rate)

  11. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)]

    Normal 12 Lead ECG (PR interval)

  12. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)]

    Normal 12 Lead ECG (QRS complex)

  13. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)]

    Normal 12 Lead ECG (QT interval and QT interval corrected for heart rate using Bazett's formula)

  14. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Auckland Clinical Studies Ltd (NZCR OpCo Limited) Grafton Auckland New Zealand 1010
2 Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited) Christchurch New Zealand 8011

Sponsors and Collaborators

  • Syneos Health
  • CuraTeQ Biologics Private Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Syneos Health
ClinicalTrials.gov Identifier:
NCT05053334
Other Study ID Numbers:
  • BP11-101
First Posted:
Sep 22, 2021
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022