Clinical trial NCT05053334: Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: CuraTeQ Biologics Private Ltd.
First posted: 2021-09-22
Enrollment: 165
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
Secondary outcomes:
measure: To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Upto 127 Days
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
measure: Safety & tolerability of BP11 with US-Xolair and EU-Xolair
timeFrame: Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
state: Queens Land
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies Ltd (NZCR OpCo Limited)
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)
Study officials:
References: