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

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ClinicalTrials.gov Identifier: NCT05053334
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : May 25, 2023
Sponsor:
Collaborator:
CuraTeQ Biologics Private Ltd.
Information provided by (Responsible Party):
Syneos Health

Study Description
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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
Healthy Volunteers 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 16, 2022
Estimated Primary Completion Date : October 16, 2023
Estimated Study Completion Date : October 16, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Upto 127 Days ]
    AUC0-t

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

  3. To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Tmax, T½

  4. To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Free IgE levels will be assessed

  5. To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Total IgE levels will be assessed

  6. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Assessment of Vital signs-Blood pressure

  7. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Assessment of Vital signs-Pulse rate

  8. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Assessment of Vital signs-Body temperature

  9. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]
    Assessment of Vital signs-Respiratory rate

  10. Safety & tolerability of BP11 with US-Xolair and EU-Xolair [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05053334


Contacts
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Contact: Disha Dadke, Dr. +91 8455255222 Disha.Dadke@curateqbio.com
Contact: Arpit Kumar Prajapati, Dr. Arpitkumar.Prajapati@curateqbio.com

Locations
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Australia, Queens Land
Q-Pharm Pty Ltd Not yet recruiting
Herston, Queens Land, Australia, 4006
Contact: Kristi McLendon, Dr    37072720 ext 07    k.mclendon@nucleusnetwork.com.au   
New Zealand
Auckland Clinical Studies Ltd (NZCR OpCo Limited) Recruiting
Grafton, Auckland, New Zealand, 1010
Contact: Leanne Barnett, Dr    093733474    leanne.barnett@nzcr.co.nz   
Principal Investigator: Leanne Barnett, Dr         
Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited) Recruiting
Christchurch, New Zealand, 8011
Contact: Chris Wynne, Dr.    033729477    Chris.Wynne@nzcr.co.nz   
Principal Investigator: Chris Wynne, Dr         
Sponsors and Collaborators
Syneos Health
CuraTeQ Biologics Private Ltd.
More Information
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Responsible Party: Syneos Health
ClinicalTrials.gov Identifier: NCT05053334    
Other Study ID Numbers: BP11-101
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents