Healthy VolunteersPhase 1NCT05053334
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
A Phase 1 study testing Omalizumab Prefilled Syringe in people with Healthy Volunteers, run by Syneos Health at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Omalizumab Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Feb 2022to 10 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.
- 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.
- 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.
- 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.
Who cannot join
- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.
- 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.
- 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.
- Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- Difficulty in blood sampling or difficulty in accessibility of veins.
- 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]).
- 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.
- Subjects with positive drug test at screening or admission.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
New Zealand2 sites
Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)
Christchurch, 8011
Auckland Clinical Studies Ltd (NZCR OpCo Limited)
Grafton, Auckland, 1010
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Omalizumab Prefilled Syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab Prefilled SyringeDrug
150mg/ml of Omalizumab prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| BP11 (Proposed biosimilar) | Experimental | Subcutaneous injection of Omalizumab developed by CuraTeQ. Receives: Drug: Omalizumab Prefilled Syringe |
| US-Xolair | Active comparator | Subcutaneous injection of Omalizumab licensed for use in USA Receives: Drug: Omalizumab Prefilled Syringe |
| EU-Xolair | Active comparator | Subcutaneous injection of Omalizumab approved for use in Europe. Receives: Drug: Omalizumab Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Upto 127 Days
Secondary outcomes (14)
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
AUC0-t
Measured: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Vd
Measured: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Tmax, T½
Measured: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Free IgE levels will be assessed
Measured: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Total IgE levels will be assessed
Measured: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Blood pressure
Measured: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Pulse rate
Measured: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Body temperature
Measured: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Respiratory rate
Measured: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Normal 12 Lead ECG (Ventricular rate)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start16 Feb 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- CuraTeQ Biologics Private Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053334
- Sponsor's protocol ID
- BP11-101
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05053334
- Acronym / sponsor ID
- BP11-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- CuraTeQ Biologics Private Ltd.
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BP11 (Proposed biosimilar) | Experimental | Drug: Omalizumab Prefilled SyringeSubcutaneous injection of Omalizumab developed by CuraTeQ. |
| US-Xolair | Active comparator | Drug: Omalizumab Prefilled SyringeSubcutaneous injection of Omalizumab licensed for use in USA |
| EU-Xolair | Active comparator | Drug: Omalizumab Prefilled SyringeSubcutaneous injection of Omalizumab approved for use in Europe. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.
- 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.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.
- 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.
- 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.
- Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- Difficulty in blood sampling or difficulty in accessibility of veins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omalizumab Prefilled Syringe150mg/ml of Omalizumab prefilled syringe | Drug | BP11 (Proposed biosimilar), EU-Xolair, US-Xolair |
Primary outcome
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
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
14 secondary outcomes
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Time frame: Upto 127 Days
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)
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)
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)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omalizumab Prefilled Syringe in people with Healthy Volunteers, run by Syneos Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.