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Trial registered on ANZCTR


Registration number
ACTRN12619000465156
Ethics application status
Approved
Date submitted
14/03/2019
Date registered
20/03/2019
Date last updated
23/07/2019
Date data sharing statement initially provided
20/03/2019
Date results information initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bioequivalence double-blind, randomized, two-parallel-group phase 1 study of a humanised anti-immunoglobulin E monoclonal antibody BP001 as Lyophilized Powder Formulation Compared with the Standard Omalizumab (Xolair®) Lyophilized Powder Formulation in healthy male volunteers
Scientific title
Bioequivalence double-blind, randomized, two-parallel-group phase 1 study of a humanised anti-immunoglobulin E monoclonal antibody BP001 as Lyophilized Powder Formulation Compared with the Standard Omalizumab (Xolair®) Lyophilized Powder Formulation in healthy male volunteers
Secondary ID [1] 297076 0
Protocol Number : BP-CSP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 311081 0
Chronic Idiopathic Urticaria 311082 0
Condition category
Condition code
Inflammatory and Immune System 309716 309716 0 0
Autoimmune diseases
Respiratory 310656 310656 0 0
Asthma
Skin 310657 310657 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study intervention is BP001 (Omalizumab), a biosimilar of Xolair® (Omalizumab).
150mg of BP001 will be administered via subcutaneous injection, once only in the upper arm, on Day 1 of the study.
n=84 subjects are to be enrolled in the study, across 2 arms.
Arm 1 (test formulation) will consist of n=42 subjects, who will be dosed once with BP001.
Arm 2 (reference formulation) will consist of n=42 subjects, who will be dosed with the comparator, Xolair®.
Intervention code [1] 313351 0
Treatment: Drugs
Comparator / control treatment
Comparator for the study is Xolair® (Omalizumab).
150mg of Xolair® will be administered via subcutaneous injection, once only, on Day 1 of the study.
Control group
Active

Outcomes
Primary outcome [1] 318681 0
Bioequivalence of BP001 with standard Xolair® formulation
Timepoint [1] 318681 0
Blood samples for Pharmacokinetics (total omalizumab) will be drawn at pre-dose (within 30 min prior to dosing) and at 6 and 12 hours post-dose on Day 1. Further blood samples for PK will be collected on study Days 2 (24hr), 3 (48hr), 4 (72hr), 6 (120hr), 7 (144hr), 8 (168hr), 11, 15, 22, 29, 43, 57, 71 and End of Study Day 85.
Secondary outcome [1] 365678 0
Immunogenicity of BP001 and standard Xolair® formulation
Timepoint [1] 365678 0
Blood samples for anti-drug antibodies (ADA) will be drawn at Screening and at pre-dose (within 30 min prior to dosing) on Day 1. Further blood samples for ADA will be collected on study Days 7 (144hr) , 15, 43 and End of Study Day 85.
Secondary outcome [2] 365680 0
Safety and tolerability of BP001 and standard Xolair® formulation
Timepoint [2] 365680 0
Specific assessments to evaluate treatment safety include the following, the type and frequency of adverse events including evaluation of site of injection, concomitant medication usage, vital signs, Physical Exmaination findings, clinical laboratory testing, and 12-lead ECGs.

Vital signs assessed at the following timepoints: Screening, Day -1, Day 1 Pre dose and 12hrs post-dose, Day 2 24hrs post-dose, Day 3 48hrs post-dose, Day 4 72hrs post-dose, Day 7, Day 8, Day 15, Day 43 and the End of Study Visit on Day 85.

Symptom Directed Physical Examination's will be performed at the following timepoints: Screening, Day -1 and Day 85.

Clinical laboratory testing for Haematology, Serum Chemistry, and Urinalysis will be performed at the following timepoints: Screening, Day -1, Day 1 12hrs post-dose, Day 2 24hrs post-dose, Day 7, Day 8, Day 15, Day 43 and End of Study Day 85.

12-lead ECGs will be performed at the following timepoints: Screening, Day -1, Day 1 pre-dose and 12hrs post-dose, Day 7, Day 8, Day 15, Day 43 and End of Study Day 85.

Concomitant medication usage will be monitored from screening until End of Study on Day 85.

Adverse events will be recorded from the time that a subject is dosed, until the End of Study visit on day 85. Site staff will question subjects on their health when conducting other assessments throughout the trial. Adverse events will be assessed by study investigators. The most common adverse reactions in clinical studies were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, earache, nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough. The IMP injection sites will be assessed for pain, redness and swelling, at the same time as the review of adverse events from dosing until Day 85.

Eligibility
Key inclusion criteria
1. Male aged 18 to 55 years, inclusive;
2. Body mass index (BMI) between 18 and 30 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg;
3. Healthy as determined by pre-study medical history, physical examination (PE), vital signs, and 12-lead electrocardiogram (ECG);
4. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus HIV-1and HIV-2 antibody at screening;
5. Normal blood chemistry values, or any abnormalities should be not clinically significant, as determined by the investigator at screening and Day -1. Serum IgE < 100 U/ml will be assessed for eligibility at screening only. Lab tests may be repeated once at the discretion of the investigator;
6. Negative screen for alcohol and drugs of abuse at screening and admission; Drugs of abuse may be repeated at the discretion of the investigator to account for a false positive ie. where a participant has consumed poppy seeds;
7. Must be practicing a highly effective method of birth control with female partners of childbearing potential from screening throughout the study and for at least 90 days after the investigational drug administration. Highly effective birth control methods include vasectomy, abstinence or condom use in combination with partner’s use of highly effective contraception (i.e. hormonal contraceptives including oral, patch, vaginal ring, implant or injection, intra uterine device (IUD), or documented evidence of surgical sterilization at least 6 months prior to screening visit (i.e. tubal ligation or hysterectomy). Subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unwillingness or inability to follow the procedures outlined in the protocol;
2. Positive drug screen at Screening or Day -1;
3. Have a history of drug abuse;
4. History of alcohol abuse;
5. Regular smokers within 2 months prior to screening. Social smokers (Less than or equal to 10 cigarettes/week) may be included if they agree to abstain for the duration of the trial;
6. Participation in studies with monoclonal antibody therapy within 6 months of Screening or previous exposure to omalizumab;
7. Participated in any other investigational clinical study in which administration of an investigational study drug occurred within 30 days or 5 half-lives of the product (whichever is the longest) prior to Screening;

8. History of clinical relevant history of allergy related diseases including hay fever, urticaria, allergic asthma, allergic rhinitis; Mild allergic conditions may be included at the discretion of the Investigator;
9. History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation;
10. Any concurrent disease, physical and/or mental condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
11. Subjects with surgical or medical conditions that may significantly alter the absorption form subcutaneous tissue, distribution, metabolism or excretion of omalizumab.

Study design
Purpose of the study
Treatment
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 12896 0
Nucleus Network - Melbourne
Recruitment hospital [2] 13973 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 25373 0
3004 - Melbourne
Recruitment postcode(s) [2] 26749 0
4007 - Herston

Funding & Sponsors
Funding source category [1] 301643 0
Commercial sector/Industry
Name [1] 301643 0
Biosana Pty Ltd
Address [1] 301643 0
National Innovation Centre
Australian Technology Park
Suite 145, 4 Cornwallis Street
Eveleigh, NSW 2015
Country [1] 301643 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biosana Pty Ltd
Address
National Innovation Centre
Australian Technology Park
Suite 145, 4 Cornwallis Street
Eveleigh, NSW 2015
Country
Australia
Secondary sponsor category [1] 301352 0
Commercial sector/Industry
Name [1] 301352 0
Avance Clinical Pty Ltd
Address [1] 301352 0
Level 1, 2 Ann Nelson Drive, Thebarton SA 5031
Country [1] 301352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302365 0
Bellberry Human Research Ethics Committee E (TGA HREC Code: EC00450)
Ethics committee address [1] 302365 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 302365 0
Australia
Date submitted for ethics approval [1] 302365 0
16/01/2019
Approval date [1] 302365 0
15/02/2019
Ethics approval number [1] 302365 0
2019-01-051

Summary
Brief summary
This is a double-blind pharmacokinetic study designed to assess bioequivalence between a test, BP001, and reference formulation, Xolair®, of 150 mg omalizumab.
The study will consist of 84 healthy male participants, each receiving a single 150 mg subcutaneous dose of BP001 or Xolair® in a randomized parallel-group design.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89974 0
Dr Jason Lickliter
Address 89974 0
Nucleus Network Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, VIC 3004 Australia
Country 89974 0
Australia
Phone 89974 0
+61 3 9089 8214
Fax 89974 0
Email 89974 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 89975 0
Dr Jason Lickliter
Address 89975 0
Nucleus Network Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, VIC 3004 Australia
Country 89975 0
Australia
Phone 89975 0
+61 3 9089 8214
Fax 89975 0
Email 89975 0
j.lickliter@nucleusnetwork.com.au
Contact person for scientific queries
Name 89976 0
Dr Jason Lickliter
Address 89976 0
Nucleus Network Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, VIC 3004 Australia
Country 89976 0
Australia
Phone 89976 0
+61 3 9089 8214
Fax 89976 0
Email 89976 0
j.lickliter@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary