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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053334
• Other study ID #: BP11-101
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2022
• Est. completion date: November 16, 2023

Study information

• Verified date: February 2023
• Source: Syneos Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston	Queens Land
New Zealand	Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)	Christchurch
New Zealand	Auckland Clinical Studies Ltd (NZCR OpCo Limited)	Grafton	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Syneos Health	CuraTeQ Biologics Private Ltd.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair	AUC0-t	Upto 127 Days
Secondary	To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair	Vd	Upto 127 Days
Secondary	To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair	Tmax, T½	Upto 127 Days
Secondary	To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair	Free IgE levels will be assessed	Upto 127 Days
Secondary	To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair	Total IgE levels will be assessed	Upto 127 Days
Secondary	Safety & tolerability of BP11 with US-Xolair and EU-Xolair	Assessment of Vital signs-Blood pressure	Upto 127 Days
Secondary	Safety & tolerability of BP11 with US-Xolair and EU-Xolair	Assessment of Vital signs-Pulse rate	Upto 127 Days
Secondary	Safety & tolerability of BP11 with US-Xolair and EU-Xolair	Assessment of Vital signs-Body temperature	Upto 127 Days
Secondary	Safety & tolerability of BP11 with US-Xolair and EU-Xolair	Assessment of Vital signs-Respiratory rate	Upto 127 Days
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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.