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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05053334
Registration number
NCT05053334
Ethics application status
Date submitted
22/08/2021
Date registered
22/09/2021
Date last updated
5/01/2024
Titles & IDs
Public title
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
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Scientific 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
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Secondary ID [1]
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BP11-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Omalizumab Prefilled Syringe
Experimental: BP11 (Proposed biosimilar) - Subcutaneous injection of Omalizumab developed by CuraTeQ.
Active Comparator: US-Xolair - Subcutaneous injection of Omalizumab licensed for use in USA
Active Comparator: EU-Xolair - Subcutaneous injection of Omalizumab approved for use in Europe.
Treatment: Drugs: Omalizumab Prefilled Syringe
150mg/ml of Omalizumab prefilled syringe
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
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Assessment method [1]
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AUC0-inf will be evaluated
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Timepoint [1]
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Upto 127 Days
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Primary outcome [2]
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To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
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Assessment method [2]
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Cmax will be evaluated
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Timepoint [2]
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Upto 127 Days
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Secondary outcome [1]
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To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
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Assessment method [1]
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AUC0-t
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Timepoint [1]
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Upto 127 Days
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Secondary outcome [2]
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To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
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Assessment method [2]
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Vd
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Timepoint [2]
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Upto 127 Days
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Secondary outcome [3]
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To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
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Assessment method [3]
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Tmax, T½
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Timepoint [3]
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Upto 127 Days
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Secondary outcome [4]
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To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
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Assessment method [4]
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Free IgE levels will be assessed
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Timepoint [4]
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Upto 127 Days
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Secondary outcome [5]
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To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
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Assessment method [5]
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Total IgE levels will be assessed
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Timepoint [5]
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Upto 127 Days
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Secondary outcome [6]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [6]
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Assessment of Vital signs-Blood pressure
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Timepoint [6]
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Upto 127 Days
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Secondary outcome [7]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [7]
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Assessment of Vital signs-Pulse rate
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Timepoint [7]
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Upto 127 Days
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Secondary outcome [8]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [8]
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Assessment of Vital signs-Body temperature
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Timepoint [8]
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Upto 127 Days
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Secondary outcome [9]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [9]
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Assessment of Vital signs-Respiratory rate
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Timepoint [9]
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Upto 127 Days
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Secondary outcome [10]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [10]
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Normal 12 Lead ECG (Ventricular rate)
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Timepoint [10]
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Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
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Secondary outcome [11]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [11]
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Normal 12 Lead ECG (PR interval)
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Timepoint [11]
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Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
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Secondary outcome [12]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [12]
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Normal 12 Lead ECG (QRS complex)
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Timepoint [12]
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Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
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Secondary outcome [13]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [13]
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Normal 12 Lead ECG (QT interval and QT interval corrected for heart rate using Bazett's formula)
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Timepoint [13]
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Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
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Secondary outcome [14]
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
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Assessment method [14]
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Assessment of injection site reaction
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Timepoint [14]
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Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/11/2023
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Sample size
Target
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Accrual to date
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Final
165
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Recruitment in Australia
Recruitment state(s)
Queens Lan
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Recruitment hospital [1]
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Q-Pharm Pty Ltd - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Syneos Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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CuraTeQ Biologics Private Ltd.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05053334
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05053334
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