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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Omalizumab Prefilled Syringe

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Disha Dadke, Dr.; Phone Number: +91 8455255222; Email: Disha.Dadke@curateqbio.com
• Study Contact Backup: Name: Arpit Kumar Prajapati, Dr.; Email: Arpitkumar.Prajapati@curateqbio.com

Study Locations

• Australia
  • Queens Land
    • Herston, Queens Land, Australia, 4006
      • Q-Pharm Pty Ltd
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Auckland Clinical Studies Ltd (NZCR OpCo Limited)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Syneos Health
• Collaborators: CuraTeQ Biologics Private Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: BP11-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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