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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
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
Secondary ID [1] 0 0
BP11-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
Timepoint [1] 0 0
Upto 127 Days
Primary outcome [2] 0 0
To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
Timepoint [2] 0 0
Upto 127 Days
Secondary outcome [1] 0 0
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Timepoint [1] 0 0
Upto 127 Days
Secondary outcome [2] 0 0
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Timepoint [2] 0 0
Upto 127 Days
Secondary outcome [3] 0 0
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Timepoint [3] 0 0
Upto 127 Days
Secondary outcome [4] 0 0
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Timepoint [4] 0 0
Upto 127 Days
Secondary outcome [5] 0 0
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Timepoint [5] 0 0
Upto 127 Days
Secondary outcome [6] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [6] 0 0
Upto 127 Days
Secondary outcome [7] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [7] 0 0
Upto 127 Days
Secondary outcome [8] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [8] 0 0
Upto 127 Days
Secondary outcome [9] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [9] 0 0
Upto 127 Days
Secondary outcome [10] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [10] 0 0
Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Secondary outcome [11] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [11] 0 0
Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Secondary outcome [12] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [12] 0 0
Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Secondary outcome [13] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [13] 0 0
Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Secondary outcome [14] 0 0
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Timepoint [14] 0 0
Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2023
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
Queens Lan
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CuraTeQ Biologics Private Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05053334
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries