Healthy VolunteersPhase 1NCT04238650
A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
A Phase 1 study testing MB02 (Bevacizumab Biosimilar) and EU approved Avastin® in people with Healthy Volunteers and Male, run by mAbxience Research S.L. at 1 site in Japan.
Trial summary
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Male, Japanese
- What is being tested?
- MB02 (Bevacizumab Biosimilar) and EU approved Avastin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteJapan
- Study dates
- 2 Aug 2019to 27 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Healthy Japanese males aged ≥20 to ≤55 years, inclusive, at Screening.
- Subjects with Body mass index (BMI) between ≥18.5 to ≤28 kg/m2 and total body weight between ≥50 and ≤100 kg, at Screening
- Subject must have no clinically relevant abnormalities identified by a detailed medical history.
- Systolic blood pressure ≤140 mm Hg and diastolic blood pressure ≤90 mm Hg.
- Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology.
Show all 28Show fewer
- All other values for hematology, coagulation and for biochemistry and urinalysis tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator, according to the following laboratory values:
- Adequate bone marrow function
- Absolute neutrophil count ≥1.5 × 109 L
- Platelet count ≥100 × 109 L
- Hemoglobin >10 g/dl
- Adequate liver function:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ ULN
- Alkaline phosphatase (ALP) ≤1.5 × ULN
- Total bilirubin <1.5 × ULN
- Serum albumin: >3.5 g/dL
- Low density lipoprotein cholesterol ≤139 mg/dL
- High density lipoprotein cholesterol ≥ 40 mg/dL
- Creatine kinase (CK) <2 ULN at D-1
- Adequate coagulation:
- International normalised ratio (INR) 0.8 to 1.3
- Adequate renal function:
- Blood urea nitrogen: ≤1.5 × ULN
- Creatinine: <1.5 mg/dL
- Urine dipstick for proteinuria <2+.
- All intermittent medications should have been stopped at least 30 days prior to admission to the clinical research center.
- Subjects agree to use contraception.
- Ability and willingness to abstain from alcoholic beverages (alcohol) 48 hours prior to admission to the clinical research center.
Who cannot join
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
- Previous treatment with an anti VEGF antibody like bevacizumab or any other protein or antibody targeting the VEGF receptor.
- History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency.
- Known history of clinically significant essential hypertension (subjects under any antihypertensive treatment included), orthostatic hypotension, fainting spells or blackouts for any reason, cardiac failure or history of thromboembolic conditions.
- History of GI perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, diverticular disease, any fistulae, pulmonary hemorrhage (hemoptysis) or reversible posterior leukoencephalopathy syndrome.
- Any out-of-range laboratory values considered clinically significant by the investigator.
Show all 25Show fewer
- 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).
- Any current or recent history of active infections, including localized 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). A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation. If subject shows positive Hepatitis B test, but results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
- Clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to Check-in, and/or positive urinary drug test screen and/or positive breath alcohol test at Screening or Check in. Average intake of more than 24 units of alcohol / wk. (1 unit of alcohol equals ~250mL of beer, 100mL of wine or 35mL of spirits). Positive urine drug screen (opiates, methadone, cocaine, amphetamines (including ecstasy or methamphetamines), cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and phencyclidine).
- Treatment with non-topical medications within 7 days prior to study drug administration, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen, which may be used throughout the study.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 60 days prior to Check-in, or within 5 half lives of the investigational drug used in the study.
- Subjects considered unsuitable for inclusion by the investigator (e.g., inability to understand and comply with the study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study).
- Strenuous exercise within seven days prior to admission to the clinical research center.
- Significant or acute illness within 15 days prior to drug administration that may impact safety assessments per the judgement of the investigator.
- Unsuitable veins for infusion and/or venepuncture.
- 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.
- 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.
- 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).
- Have received a live or attenuated vaccine from 3 months prior to Screening or have the intention to receive a vaccine during the study.
- Intend to travel to a region where a vaccination will be required due to endemic disease within 3 months of dosing.
- Use of tobacco- or nicotine-containing products within 1 year prior to Check-in, or positive cotinine test upon Screening or Check-in.
- Receipt of blood products within 60 days prior to Check-in.
- Person who performed blood sampling more than 400 mL within 90 days before administration of investigational drug, more than 200 mL blood within 30 days, or blood donation of blood plasma / platelet component within 14 days.
- History of abnormal peripheral sensation including paraesthesia and/or numbness in arms and/or legs.
- Have previously received Bevacizumab either under present study or under any other circumstances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers.
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.
Read the detailed description
The primary PK parameter endpoint is AUC(0-∞) for bevacizumab. The secondary PK endpoints will include all other PK parameters for bevacizumab, including Cmax, tmax, t1/2, CL and AUClast.
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 AUClast. 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 versus EU Avastin®
A mixed effects model with treatment arm as fixed effect will be used to compare natural-logarithmic transformed PK parameters (AUC[0-∞+, AUClast and Cmax) between the two treatment arms (MB02 vs EU-approved Avastin®)
PK similarity between arms will be concluded if the 90% confidence intervals (CIs) for the geometric mean test/reference ratio of AUC(0-∞) fell within the predefined 0.80-1.25 bioequivalence interval.
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 titers, 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, EU 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.
- Conditions
- Healthy Volunteers, Male, Japanese
- Being tested
- MB02 (Bevacizumab Biosimilar), EU approved Avastin®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB02 (Bevacizumab Biosimilar)Drug
Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion
EU approved Avastin®Drug
Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion
| Study group | Role | What they receive |
|---|---|---|
| MB02 (Bevacizumab Biosimilar) | Experimental | Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. Receives: Drug: MB02 (Bevacizumab Biosimilar) |
| EU approved Avastin® | Active comparator | Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. Receives: Drug: EU approved Avastin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve From Time Zero to Infinity [AUC(0-∞)]
To compare the pharmacokinetic (PK) profiles of MB02 and EU Avastin® (in terms of AUC(0-∞)]) in Japanese population to establish bioequivalence between the 2 study drugs.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Secondary outcomes (8)
Maximum Observed Serum Concentration (Cmax)
To evaluate and compare the Cmax of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Observable Concentration (AUClast)
To evaluate and compare the AUClast of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Time of Maximum Observed Serum Concentration (Tmax)
To evaluate and compare the tmax of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Apparent Serum Terminal Elimination Half Life (t1/2)
To evaluate and compare the t1/2 of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Total Body Clearance (CL)
To evaluate and compare the CL of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Volume of Distribution (Vz)
To evaluate and compare the Vz of MB02 and EU Avastin® in Japanese population.
Measured: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Incidence of Treatment-related Adverse Events (Safety)
Compare the incidence of TEAEs reported in each treatment arm using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Day 1 - Day 70
Incidence of ADA Including Nab (Immunogenicity)
Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab). Subjects who tested positive at baseline are not included here.
Measured: Day -1, Day 14, 28, 50 and 70.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start2 Aug 2019
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takashi ETO, MD, Principal investigator, SOUSEIKAI Hakata Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238650
- Sponsor's protocol ID
- MB02 A 04-18
- Status last verified
- Feb 2021
- First submitted
- 16 Jan 2020
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eto T, Karasuyama Y, Gonzalez V, Del Campo Garcia A. A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers. Cancer Chemother Pharmacol. 2021 Oct;88(4):713-722. doi: 10.1007/s00280-021-04324-z. Epub 2021 Jul 16.
PubMed 34269848
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04238650
- Acronym / sponsor ID
- MB02 A 04-18
- Conditions
- Healthy Volunteers, Male, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers.
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.
Detailed description
The primary PK parameter endpoint is AUC(0-∞) for bevacizumab. The secondary PK endpoints will include all other PK parameters for bevacizumab, including Cmax, tmax, t1/2, CL and AUClast.
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 AUClast. 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 versus EU Avastin®
A mixed effects model with treatment arm as fixed effect will be used to compare natural-logarithmic transformed PK parameters (AUC[0-∞+, AUClast and Cmax) between the two treatment arms (MB02 vs EU-approved Avastin®)
PK similarity between arms will be concluded if the 90% confidence intervals (CIs) for the geometric mean test/reference ratio of AUC(0-∞) fell within the predefined 0.80-1.25 bioequivalence interval.
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 titers, 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, EU 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB02 (Bevacizumab Biosimilar) | Experimental | Drug: MB02 (Bevacizumab Biosimilar)Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. |
| EU approved Avastin® | Active comparator | Drug: EU approved Avastin®Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- 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.
- Healthy Japanese males aged ≥20 to ≤55 years, inclusive, at Screening.
- Subjects with Body mass index (BMI) between ≥18.5 to ≤28 kg/m2 and total body weight between ≥50 and ≤100 kg, at Screening
- Subject must have no clinically relevant abnormalities identified by a detailed medical history.
- Systolic blood pressure ≤140 mm Hg and diastolic blood pressure ≤90 mm Hg.
Key exclusion criteria (25 listed)
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
- Previous treatment with an anti VEGF antibody like bevacizumab or any other protein or antibody targeting the VEGF receptor.
- History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency.
- Known history of clinically significant essential hypertension (subjects under any antihypertensive treatment included), orthostatic hypotension, fainting spells or blackouts for any reason, cardiac failure or history of thromboembolic conditions.
- History of GI perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, diverticular disease, any fistulae, pulmonary hemorrhage (hemoptysis) or reversible posterior leukoencephalopathy syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB02 (Bevacizumab Biosimilar)Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion | Drug | MB02 (Bevacizumab Biosimilar) |
| EU approved Avastin®Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion | Drug | EU approved Avastin® |
Primary outcome
Area Under the Serum Concentration-time Curve From Time Zero to Infinity [AUC(0-∞)]
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
To compare the pharmacokinetic (PK) profiles of MB02 and EU Avastin® (in terms of AUC(0-∞)]) in Japanese population to establish bioequivalence between the 2 study drugs.
8 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Observable Concentration (AUClast)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Apparent Serum Terminal Elimination Half Life (t1/2)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Total Body Clearance (CL)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Volume of Distribution (Vz)
Time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.
Incidence of Treatment-related Adverse Events (Safety)
Time frame: Day 1 - Day 70
Incidence of ADA Including Nab (Immunogenicity)
Time frame: Day -1, Day 14, 28, 50 and 70.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34269848Eto T, Karasuyama Y, Gonzalez V, Del Campo Garcia A. A randomized, single-dose, pharmacokinetic equivalence study comparing MB02 (proposed biosimilar) and reference bevacizumab in healthy Japanese male volunteers. Cancer Chemother Pharmacol. 2021 Oct;88(4):713-722. doi: 10.1007/s00280-021-04324-z. Epub 2021 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takashi ETO, MD principal investigator
SOUSEIKAI Hakata Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB02 (Bevacizumab Biosimilar) and EU approved Avastin® in people with Healthy Volunteers and Male, run by mAbxience Research S.L. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Serum Concentration-time Curve From Time Zero to Infinity [AUC(0-∞)] (time frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.