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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04408989




Registration number
NCT04408989
Ethics application status
Date submitted
26/05/2020
Date registered
1/06/2020

Titles & IDs
Public title
A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®.
Scientific title
A Randomized, Double-Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02-SP, MB02-DM (Bevacizumab Biosimilar Drugs) and US-licensed Avastin® in Healthy Male Volunteers
Secondary ID [1] 0 0
MB02-A-06-20
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 - MB02-SP
Treatment: Drugs - MB02-DM
Treatment: Drugs - US licenced Avastin®

Experimental: MB02-SP (Bevacizumab Biosimilar) - Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.

Experimental: MB02-DM (Bevacizumab Biosimilar) - Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.

Active comparator: US licenced Avastin® - Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.


Treatment: Drugs: MB02-SP
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Treatment: Drugs: MB02-DM
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Treatment: Drugs: US licenced Avastin®
Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics (PK) - (AUC[0-8])
Timepoint [1] 0 0
Day 1 - Day 100
Primary outcome [2] 0 0
Pharmacokinetics (PK) - (Cmax)
Timepoint [2] 0 0
Day 1 - Day 100
Secondary outcome [1] 0 0
Other PK parameters (tmax)
Timepoint [1] 0 0
Day 1 - Day 100
Secondary outcome [2] 0 0
Other PK parameters (AUC[0 t])
Timepoint [2] 0 0
Day 1 - Day 100
Secondary outcome [3] 0 0
Other PK parameters (CL)
Timepoint [3] 0 0
Day 1 - Day 100
Secondary outcome [4] 0 0
Other PK parameters (t1/2)
Timepoint [4] 0 0
Day 1 - Day 100
Secondary outcome [5] 0 0
Immunogenicity
Timepoint [5] 0 0
Day 1 - Day 78
Secondary outcome [6] 0 0
Safety (Incidence of Treatment-related Adverse Events)
Timepoint [6] 0 0
Day 1 - Day 100

Eligibility
Key inclusion criteria
1. Males of any race, between 18 and 55 years of age, inclusive, at Screening.
2. Body mass index between 18.5 and 29.9 kg/m2, inclusive, at Screening.
3. Total body weight between 50 and 95 kg, inclusive, at Screening.
4. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
5. Relevant clinical laboratory evaluations of haematology, coagulation, urinalysis and clinical chemistry within normal range at Screening and Check in as follows. A single repeat test will be allowed at each timepoint.

* Absolute neutrophil count =1.5 × 109 L
* Platelet count =100 × 109 L
* Haemoglobin >10 g/dl
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5 x ULN
* Alkaline phosphatase (ALP) =1.5 × ULN
* Total bilirubin <1.5 × ULN (<51.30 µmol/L in subjects with Gilbert's syndrome)
* Blood urea nitrogen =1.5 × ULN
* Creatinine <132.63 µmol/L
* Serum albumin: >35 g/L
* Low density lipoprotein cholesterol = 4.9 mmol/L
* High density lipoprotein cholesterol = 0.85 mmol/L
* Creatine kinase (CK) <2 × ULN
* International normalised ratio (INR) 0.8 to 1.3
* Urine dipstick for proteinuria <2+
6. Systolic blood pressure =90 mmHg and <140 mmHg and diastolic blood pressure =50 mmHg and <90 mmHg at Screening and Check in.
7. Subjects agree to use contraception.
8. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Subjects must have signed an informed consent before any study-related procedure or evaluation is performed.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
3. Any current or recent history of active infections, including localised infections (Within 2 months prior Screening Visit for any serious infection which requires hospitalization or intravenous anti-infective, and within 14 days prior Screening Visit for any active infection which requires oral treatment).
4. History of, or planned surgery, including suturing, dental surgery or wound dehiscence within 30 days of dosing, or within 30 days of the last study visit.
5. Presence of a nonhealing wound or fracture.
6. Known history of clinically significant essential hypertension, orthostatic hypotension, fainting spells or blackouts for any reason, cardiac failure or history of thromboembolic conditions.
7. Medically significant dental disease or dental neglect, with signs and/or symptoms of local or systemic infection that would likely require a dental procedure during the course of the study.
8. Clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to Check-in, and/or positive alcohol breath test and/or urinary drug test screen (confirmed by repeat) at Screening or Check in.
9. History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency.
10. History of clinically significant haemorrhage, epistaxis, GI bleeding, haemorrhoids and/or haemoptysis.
11. History of GI perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, or any fistulae.
12. Alcohol consumption of >24 units per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
13. Positive hepatitis panel, positive human immunodeficiency test. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in, or within 5 half lives of the investigational drug used in the study.
15. Use or intend to use slow-release medications/products considered to still be active within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
16. Use or intend use of any prescription medications/ nonprescription products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator or designee.
17. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
18. Have received a live or attenuated vaccine from 3 months prior to Screening or have the intention to receive a vaccine during the study.
19. Intend to travel to a region where a vaccination will be required due to endemic disease within 3 months of dosing.
20. Previous treatment with an anti VEGF antibody or any other protein or antibody targeting the VEGF receptor.
21. Use of tobacco- or nicotine-containing products within 1 year prior to Check-in, or positive cotinine test upon Screening or Check-in.
22. Receipt of blood products within 60 days prior to Check-in.
23. Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening.
24. Poor peripheral venous access.
25. History of abnormal peripheral sensation including paraesthesia and/or numbness in arms and/or legs.
26. Have previously completed or withdrawn from this study or any other study investigating bevacizumab, and/or have previously received bevacizumab.
27. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
28. Vulnerable subjects (e.g. persons kept in detention).
29. Subjects who are study site employees or immediate family members of a study site or Mabxience employee.

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 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
11/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/09/2021
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
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
Commercial sector/industry
Name
mAbxience Research S.L.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Schwabe, MD
Address 0 0
Auckland Clinical Studies
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04408989