A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®.

NCT04408989 | Completed Phase 1 Results

• 1 other identifier: MB02-A-06-20
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-Avastin® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK) - (AUC[0-∞])

  Compare the pharmacokinetic (PK) profiles of the 3 arms (AUC\[0-∞\])

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

• Pharmacokinetics (PK) - (Cmax)

  Compare the pharmacokinetic (PK) profiles of the 3 arms (Cmax)

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

Secondary Outcomes (7)

• Other PK Parameters (Tmax)

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

• Other PK Parameters (AUC[0 t])

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

• Other PK Parameters (CL)

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

• Other PK Parameters (t1/2)

  Pre-dose (0 hours),end of infusion, 2, 3, 4, 5, 6, 7, 12, and 24 hours and at Days 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 42, 56, 78, and 100 post-dose

• Immunogenicity

  Days -1, 14, 28, 56 and 78

Study Arms (3)

MB02-SP (Bevacizumab Biosimilar)

EXPERIMENTAL

Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.

Drug: MB02-SP

MB02-DM (Bevacizumab Biosimilar)

EXPERIMENTAL

Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.

Drug: MB02-DM

US licenced Avastin®

ACTIVE COMPARATOR

Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.

Drug: US licenced Avastin®

Interventions

MB02-SP DRUG

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Also known as: MB02-SP (Bevacizumab Biosimilar)

MB02-SP (Bevacizumab Biosimilar)

MB02-DM DRUG

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Also known as: MB02-DM (Bevacizumab Biosimilar)

MB02-DM (Bevacizumab Biosimilar)

US licenced Avastin® DRUG

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Also known as: Bevacizumab (US sourced)

US licenced Avastin®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only male subjects may be enrolled
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males of any race, between 18 and 55 years of age, inclusive, at Screening.
• Body mass index between 18.5 and 29.9 kg/m2, inclusive, at Screening.
• Total body weight between 50 and 95 kg, inclusive, at Screening.
• 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).
• 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

You may not qualify if:

• 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).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• 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).
• 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.
• Presence of a nonhealing wound or fracture.
• Known history of clinically significant essential hypertension, orthostatic hypotension, fainting spells or blackouts for any reason, cardiac failure or history of thromboembolic conditions.
• 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.
• 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.
• History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency.
• History of clinically significant haemorrhage, epistaxis, GI bleeding, haemorrhoids and/or haemoptysis.
• History of GI perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, or any fistulae.
• 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.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (2)

Auckland Clinical Studies

Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Susana Millan
• Organization: mabxience Research SL

susana.millan@mabxience.com

+3491771500

Study Officials

• Christian Schwabe, MD

  Auckland Clinical Studies

  PRINCIPAL INVESTIGATOR

• Alexandra Cole, MD

  Christchurch Clinical Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: January 11, 2021
• Primary Completion: August 20, 2021
• Study Completion: September 2, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2022-06

Locations

NZ (2)