<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408989</url>
  </required_header>
  <id_info>
    <org_study_id>MB02-A-06-20</org_study_id>
    <nct_id>NCT04408989</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and USlicensed Avastin®.</brief_title>
  <official_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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>mAbxience Research S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>mAbxience Research S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare&#xD;
      the PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-Avastin® in healthy&#xD;
      male subjects.&#xD;
&#xD;
      During the course of the study, the similarity in pharmacokinetics will be assessed by&#xD;
      sampling the levels of drug in the blood, and by comparing these levels among the different&#xD;
      administration arms. Safety, tolerability, and immunologic response to the administered drugs&#xD;
      will also be evaluated throughout.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary PK parameter endpoints are Cmax and AUC0-∞ for bevacizumab. The secondary PK&#xD;
      endpoints will include all other PK parameters for bevacizumab, including tmax, t1/2, CL and&#xD;
      AUC(0-t).&#xD;
&#xD;
      The serum PK parameters of bevacizumab will be calculated using standard noncompartmental&#xD;
      methods. An analysis of covariance model will be used to analyse the log-transformed primary&#xD;
      PK parameters (AUC[0 ∞] and Cmax) and AUC(0-t). The model will include a fixed effect for&#xD;
      treatment and body weight as a covariate.&#xD;
&#xD;
      All other PK parameters will not be subject to inferential statistical analysis.&#xD;
&#xD;
      Estimates of geometric mean ratios together with the corresponding 90% confidence intervals&#xD;
      (CI) will be derived for the comparisons of the PK parameters as follows:&#xD;
&#xD;
        -  MB02-SP versus MB02-DM&#xD;
&#xD;
        -  MB02-SP versus US Avastin®&#xD;
&#xD;
        -  MB02-DM versus US Avastin® PK similarity will be achieved if the 90% CIs for the&#xD;
           biosimilar-to-reference ratios of PK endpoints (AUC[0-∞] and Cmax) fall within the&#xD;
           predefined 0.80-1.25 acceptance similarity criteria for all 3 pairwise comparisons;&#xD;
           MB02-SP versus MB02-DM; MB02-SP versus US Avastin®; and MB02-DM versus US Avastin®.&#xD;
&#xD;
      All AEs will be listed and summarised using descriptive methodology. All observed or&#xD;
      patient-reported AEs will be graded by the National Cancer Institute Common Terminology&#xD;
      Criteria for Adverse Events version 5.0. The incidence of AEs for each treatment will be&#xD;
      presented by severity and by association with the study drugs as determined by the&#xD;
      Investigator (or designee). Each AE will be coded using the Medical Dictionary for Regulatory&#xD;
      Activities. All safety data will be listed and summarised as appropriate.&#xD;
&#xD;
      Immunogenicity data (overall ADA incidence and titters, and neutralising ADA results) will be&#xD;
      listed. A summary of the number and percent of subjects testing positive for ADA or&#xD;
      neutralising antibodies before the dose of MB02-SP, MB02-DM, or US Avastin® (Day -1) and at&#xD;
      scheduled post dose assessments will be presented by treatment arm. All safety data and&#xD;
      immunogenicity data summaries will be based on the safety analysis population. Select&#xD;
      analyses may be repeated for subsets with or without ADA and de novo ADA formation as&#xD;
      appropriate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Anticipated">August 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) - (AUC[0-∞])</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Compare the pharmacokinetic (PK) profiles of the 3 arms (AUC[0-∞])</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) - (Cmax)</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Compare the pharmacokinetic (PK) profiles of the 3 arms (Cmax)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other PK parameters (tmax)</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Evaluation of all other PK parameters (tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other PK parameters (AUC[0 t])</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Evaluation of all other PK parameters (AUC[0 t])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other PK parameters (CL)</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Evaluation of all other PK parameters (CL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other PK parameters (t1/2)</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Evaluation of all other PK parameters (t1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>Day 1 - Day 78</time_frame>
    <description>Incidence of anti-bevacizumab antiboides (ADA), including neutralizing antibodies (Nab)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (Incidence of Treatment-related Adverse Events)</measure>
    <time_frame>Day 1 - Day 100</time_frame>
    <description>Incidence of Treatment-related Adverse Events using CTCAE v5.0</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>MB02-SP (Bevacizumab Biosimilar)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MB02-DM (Bevacizumab Biosimilar)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US licenced Avastin®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MB02-SP</intervention_name>
    <description>Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion</description>
    <arm_group_label>MB02-SP (Bevacizumab Biosimilar)</arm_group_label>
    <other_name>MB02-SP (Bevacizumab Biosimilar)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MB02-DM</intervention_name>
    <description>Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion</description>
    <arm_group_label>MB02-DM (Bevacizumab Biosimilar)</arm_group_label>
    <other_name>MB02-DM (Bevacizumab Biosimilar)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>US licenced Avastin®</intervention_name>
    <description>Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion</description>
    <arm_group_label>US licenced Avastin®</arm_group_label>
    <other_name>Bevacizumab (US sourced)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males of any race, between 18 and 55 years of age, inclusive, at Screening.&#xD;
&#xD;
          2. Body mass index between 18.5 and 29.9 kg/m2, inclusive, at Screening.&#xD;
&#xD;
          3. Total body weight between 50 and 95 kg, inclusive, at Screening.&#xD;
&#xD;
          4. In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory&#xD;
             evaluations (congenital non-haemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is&#xD;
             acceptable) at Screening or Check-in as assessed by the Investigator (or designee).&#xD;
&#xD;
          5. Relevant clinical laboratory evaluations of haematology, coagulation, urinalysis and&#xD;
             clinical chemistry within normal range at Screening and Check in as follows. A single&#xD;
             repeat test will be allowed at each timepoint.&#xD;
&#xD;
               -  Absolute neutrophil count ≥1.5 × 109 L&#xD;
&#xD;
               -  Platelet count ≥100 × 109 L&#xD;
&#xD;
               -  Haemoglobin &gt;10 g/dl&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase (ALP) ≤1.5 × ULN&#xD;
&#xD;
               -  Total bilirubin &lt;1.5 × ULN (&lt;51.30 µmol/L in subjects with Gilbert's syndrome)&#xD;
&#xD;
               -  Blood urea nitrogen ≤1.5 × ULN&#xD;
&#xD;
               -  Creatinine &lt;132.63 µmol/L&#xD;
&#xD;
               -  Serum albumin: &gt;35 g/L&#xD;
&#xD;
               -  Low density lipoprotein cholesterol ≤ 4.9 mmol/L&#xD;
&#xD;
               -  High density lipoprotein cholesterol ≥ 0.85 mmol/L&#xD;
&#xD;
               -  Creatine kinase (CK) &lt;2 × ULN&#xD;
&#xD;
               -  International normalised ratio (INR) 0.8 to 1.3&#xD;
&#xD;
               -  Urine dipstick for proteinuria &lt;2+&#xD;
&#xD;
          6. Systolic blood pressure ≥90 mmHg and &lt;140 mmHg and diastolic blood pressure ≥50 mmHg&#xD;
             and &lt;90 mmHg at Screening and Check in.&#xD;
&#xD;
          7. Subjects agree to use contraception.&#xD;
&#xD;
          8. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by&#xD;
             the study restrictions. Subjects must have signed an informed consent before any&#xD;
             study-related procedure or evaluation is performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, haematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as&#xD;
             determined by the Investigator (or designee).&#xD;
&#xD;
          2. History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance, unless approved by the Investigator (or designee).&#xD;
&#xD;
          3. Any current or recent history of active infections, including localised infections&#xD;
             (Within 2 months prior Screening Visit for any serious infection which requires&#xD;
             hospitalization or intravenous anti-infective, and within 14 days prior Screening&#xD;
             Visit for any active infection which requires oral treatment).&#xD;
&#xD;
          4. History of, or planned surgery, including suturing, dental surgery or wound dehiscence&#xD;
             within 30 days of dosing, or within 30 days of the last study visit.&#xD;
&#xD;
          5. Presence of a nonhealing wound or fracture.&#xD;
&#xD;
          6. Known history of clinically significant essential hypertension, orthostatic&#xD;
             hypotension, fainting spells or blackouts for any reason, cardiac failure or history&#xD;
             of thromboembolic conditions.&#xD;
&#xD;
          7. Medically significant dental disease or dental neglect, with signs and/or symptoms of&#xD;
             local or systemic infection that would likely require a dental procedure during the&#xD;
             course of the study.&#xD;
&#xD;
          8. Clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to&#xD;
             Check-in, and/or positive alcohol breath test and/or urinary drug test screen&#xD;
             (confirmed by repeat) at Screening or Check in.&#xD;
&#xD;
          9. History of bleeding disorders or protein C, protein S, and/or factor V Leiden&#xD;
             deficiency.&#xD;
&#xD;
         10. History of clinically significant haemorrhage, epistaxis, GI bleeding, haemorrhoids&#xD;
             and/or haemoptysis.&#xD;
&#xD;
         11. History of GI perforation, ulcers, gastro oesophageal reflux, inflammatory bowel&#xD;
             disease, diverticular disease, or any fistulae.&#xD;
&#xD;
         12. Alcohol consumption of &gt;24 units per week. One unit of alcohol equals ½ pint (285 mL)&#xD;
             of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.&#xD;
&#xD;
         13. Positive hepatitis panel, positive human immunodeficiency test. Subjects whose results&#xD;
             are compatible with prior immunisation and not infection may be included at the&#xD;
             discretion of the Investigator.&#xD;
&#xD;
         14. Participation in a clinical study involving administration of an investigational drug&#xD;
             (new chemical entity) in the past 90 days prior to Check-in, or within 5 half lives of&#xD;
             the investigational drug used in the study.&#xD;
&#xD;
         15. Use or intend to use slow-release medications/products considered to still be active&#xD;
             within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or&#xD;
             designee).&#xD;
&#xD;
         16. Use or intend use of any prescription medications/ nonprescription products known to&#xD;
             alter drug absorption, metabolism, or elimination processes, including St. John's&#xD;
             wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator&#xD;
             or designee.&#xD;
&#xD;
         17. Use or intend to use any nonprescription medications/products including vitamins,&#xD;
             minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior&#xD;
             to Check-in, unless deemed acceptable by the Investigator (or designee).&#xD;
&#xD;
         18. Have received a live or attenuated vaccine from 3 months prior to Screening or have&#xD;
             the intention to receive a vaccine during the study.&#xD;
&#xD;
         19. Intend to travel to a region where a vaccination will be required due to endemic&#xD;
             disease within 3 months of dosing.&#xD;
&#xD;
         20. Previous treatment with an anti VEGF antibody or any other protein or antibody&#xD;
             targeting the VEGF receptor.&#xD;
&#xD;
         21. Use of tobacco- or nicotine-containing products within 1 year prior to Check-in, or&#xD;
             positive cotinine test upon Screening or Check-in.&#xD;
&#xD;
         22. Receipt of blood products within 60 days prior to Check-in.&#xD;
&#xD;
         23. Donation of blood from 90 days prior to Screening, plasma from 14 days prior to&#xD;
             Screening, or platelets from 42 days prior to Screening.&#xD;
&#xD;
         24. Poor peripheral venous access.&#xD;
&#xD;
         25. History of abnormal peripheral sensation including paraesthesia and/or numbness in&#xD;
             arms and/or legs.&#xD;
&#xD;
         26. Have previously completed or withdrawn from this study or any other study&#xD;
             investigating bevacizumab, and/or have previously received bevacizumab.&#xD;
&#xD;
         27. Subjects who, in the opinion of the Investigator (or designee), should not participate&#xD;
             in this study.&#xD;
&#xD;
         28. Vulnerable subjects (e.g. persons kept in detention).&#xD;
&#xD;
         29. Subjects who are study site employees or immediate family members of a study site or&#xD;
             Mabxience employee.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only male subjects may be enrolled</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Schwabe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auckland Clinical Studies</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandra Cole, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christchurch Clinical Studies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Auckland Clinical Studies</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 24, 2021</last_update_submitted>
  <last_update_submitted_qc>June 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 7, 2022</submitted>
    <returned>March 17, 2023</returned>
    <submitted>May 18, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408989
org study id: MB02-A-06-20
nct id: NCT04408989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
The primary PK parameter endpoints are Cmax and AUC0-∞ for bevacizumab. The secondary PK
      endpoints will include all other PK parameters for bevacizumab, including tmax, t1/2, CL and
      AUC(0-t).

      The serum PK parameters of bevacizumab will be calculated using standard noncompartmental
      methods. An analysis of covariance model will be used to analyse the log-transformed primary
      PK parameters (AUC[0 ∞] and Cmax) and AUC(0-t). The model will include a fixed effect for
      treatment and body weight as a covariate.

      All other PK parameters will not be subject to inferential statistical analysis.

      Estimates of geometric mean ratios together with the corresponding 90% confidence intervals
      (CI) will be derived for the comparisons of the PK parameters as follows:

        -  MB02-SP versus MB02-DM

        -  MB02-SP versus US Avastin®

        -  MB02-DM versus US Avastin® PK similarity will be achieved if the 90% CIs for the
           biosimilar-to-reference ratios of PK endpoints (AUC[0-∞] and Cmax) fall within the
           predefined 0.80-1.25 acceptance similarity criteria for all 3 pairwise comparisons;
           MB02-SP versus MB02-DM; MB02-SP versus US Avastin®; and MB02-DM versus US Avastin®.

      All AEs will be listed and summarised using descriptive methodology. All observed or
      patient-reported AEs will be graded by the National Cancer Institute Common Terminology
      Criteria for Adverse Events version 5.0. The incidence of AEs for each treatment will be
      presented by severity and by association with the study drugs as determined by the
      Investigator (or designee). Each AE will be coded using the Medical Dictionary for Regulatory
      Activities. All safety data will be listed and summarised as appropriate.

      Immunogenicity data (overall ADA incidence and titters, and neutralising ADA results) will be
      listed. A summary of the number and percent of subjects testing positive for ADA or
      neutralising antibodies before the dose of MB02-SP, MB02-DM, or US Avastin® (Day -1) and at
      scheduled post dose assessments will be presented by treatment arm. All safety data and
      immunogenicity data summaries will be based on the safety analysis population. Select
      analyses may be repeated for subsets with or without ADA and de novo ADA formation as
      appropriate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Pharmacokinetics (PK) - (AUC[0-∞])
time frame: Day 1 - Day 100
description: Compare the pharmacokinetic (PK) profiles of the 3 arms (AUC[0-∞])
measure: Pharmacokinetics (PK) - (Cmax)
time frame: Day 1 - Day 100
description: Compare the pharmacokinetic (PK) profiles of the 3 arms (Cmax)
measure: Other PK parameters (tmax)
time frame: Day 1 - Day 100
description: Evaluation of all other PK parameters (tmax)
measure: Other PK parameters (AUC[0 t])
time frame: Day 1 - Day 100
description: Evaluation of all other PK parameters (AUC[0 t])
measure: Other PK parameters (CL)
time frame: Day 1 - Day 100
description: Evaluation of all other PK parameters (CL)
measure: Other PK parameters (t1/2)
time frame: Day 1 - Day 100
description: Evaluation of all other PK parameters (t1/2)
measure: Immunogenicity
time frame: Day 1 - Day 78
description: Incidence of anti-bevacizumab antiboides (ADA), including neutralizing antibodies (Nab)
measure: Safety (Incidence of Treatment-related Adverse Events)
time frame: Day 1 - Day 100
description: Incidence of Treatment-related Adverse Events using CTCAE v5.0
arm group label: MB02-SP (Bevacizumab Biosimilar)
arm group type: Experimental
description: Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
arm group label: MB02-DM (Bevacizumab Biosimilar)
arm group type: Experimental
description: Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
arm group label: US licenced Avastin®
arm group type: Active Comparator
description: Sterile vial 100mg/4ml, single-dose 1mg/kg administered as 90-minute infusion on day 1.
intervention type: Drug
intervention name: MB02-SP
description: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
arm group label: MB02-SP (Bevacizumab Biosimilar)
other name: MB02-SP (Bevacizumab Biosimilar)
intervention type: Drug
intervention name: MB02-DM
description: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
arm group label: MB02-DM (Bevacizumab Biosimilar)
other name: MB02-DM (Bevacizumab Biosimilar)
intervention type: Drug
intervention name: US licenced Avastin®
description: Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
arm group label: US licenced Avastin®
other name: Bevacizumab (US sourced)
criteria: 
gender: Male
gender based: Yes
gender description: Only male subjects may be enrolled
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Schwabe, MD
role: Principal Investigator
affiliation: Auckland Clinical Studies
last name: Alexandra Cole, MD
role: Principal Investigator
affiliation: Christchurch Clinical Studies
facility: 
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Bevacizumab
sharing ipd: Undecided
submitted: June 7, 2022
returned: March 17, 2023
submitted: May 18, 2023