Healthy VolunteersPhase 1NCT03293654
A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
A Phase 1 study testing MB02, US licenced Avastin® and EU approved Avastin® in people with Healthy Volunteers, run by mAbxience Research S.L. at 2 sites in United Kingdom.
Trial summary
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the Pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MB02, US licenced Avastin® and EU approved Avastin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Dec 2017to 29 May 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 60 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 nonhaemolytic 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
Show all 22Show fewer
- Platelet count ≥100 × 109 L
- Haemoglobin >10 g/dl
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 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 ≤ ULN
- High density lipoprotein cholesterol ≥ lower limit of normal
- Creatine kinase (CK) < × 2 ULN
- International normalised ratio (INR) 0.8-1.3
- Urine dipstick for proteinuria <2+
- Systolic blood pressure ≥90 mmHg and ≤140 mmHg and diastolic blood pressure ≥50 mmHg and ≤90 mmHg at Screening and Check in.
- Subjects agree to use contraception as detailed in protocol.
- 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.
Who cannot join
- 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.
- 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.
Show all 27Show fewer
- 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 at Screening or Check in.
- History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency.
- History of clinically signifiant 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).
- 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.
- 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).
- 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.
- Previous treatment with an anti VEGF antibody or any other protein or antibody targeting the VEGF receptor.
- Use of tobacco- or nicotine-containing products within 5 years prior to Check-in, or positive cotinine test upon Screening or Check-in.
- Receipt of blood products within 60 days prior to Check-in.
- Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening.
- Poor peripheral venous access.
- History of abnormal peripheral sensation including paraesthesia and/or numbness in arms and/or legs.
- Have previously completed or withdrawn from this study or any other study investigating bevacizumab, and/or have previously received bevacizumab.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
PAREXEL International - Northwick Park Hospital
Harrow, HA1 3UJ
Covance Clinical Research Unit Limited
Leeds, LS2 9LH
About this study
Official title: A Randomised, Double Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US Licenced Avastin® and EU Approved Avastin® in Healthy Male Volunteers
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the Pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU 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.
Read the detailed description
The primary PK parameters are Cmax and AUC(0-∞). The PK parameters for 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 will be derived for the comparisons of the PK parameters as follows:
- MB02 versus EU Avastin®
- MB02 versus US Avastin®
- EU Avastin® versus US Avastin®
PK similarity will be achieved if the 90% confidence intervals (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 versus EU-approved Avastin®; MB02 versus US-licenced Avastin®; and EU-approved Avastin® versus US-licenced 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 (CTCAE) version 4.03. 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). All safety data will be listed and summarised as appropriate
Immunogenicity data (overall anti-drug antibody [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®, or US Avastin® (Day 1) and at scheduled postdose assessments will be presented by treatment arm.
- Conditions
- Healthy Volunteers
- Being tested
- MB02, US licenced Avastin®, EU approved Avastin®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB02Drug
Also called MB02 (Bevacizumab Biosimilar)
Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion.
US licenced Avastin®Drug
Also called Bevacizumab (United States)
Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion.
EU approved Avastin®Drug
Also called Bevacizumab (European Union)
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 |
| US licenced Avastin® | Active comparator | Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. Receives: Drug: US licenced Avastin® |
| 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.
Cmax: Maximum Observed Serum Concentration
To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of Cmax) to establish bioequivalence between the 3 study arms.
For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric LS means ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
AUC(0-∞); Area Under the Serum Concentration-time Curve From Time Zero to Infinity
To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of AUC[0-∞]) to establish bioequivalence between the 3 study arms.
For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric least square means (GLSM) ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
Secondary outcomes (6)
Tmax: Time of Maximum Observed Serum Concentration
To evaluate the tmax of MB02, US Avastin® and EU Avastin® .
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
AUC(0-t) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Observable Concentration;
To evaluate the AUC[0-t] of MB02, US Avastin® and EU Avastin®.
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
CL: Total Body Drug Clearance After IV Administration
To evaluate the CL of MB02, US Avastin® and EU Avastin®
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
t1/2: Apparent Serum Terminal Elimination Half-life
To evaluate the t1/2 of MB02, US Avastin® and EU Avastin®
Measured: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
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, 56, and 78
Safety (Incidence of Treatment-related Adverse Events Using CTCAE v4.03)
Compare the incidence of TEAEs reported in each treatment arm.
Measured: Day 1 - Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start7 Dec 2017
- Primary completion29 May 2019
- Study completion29 May 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.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunu Valasseri, MBBS, MSc, Principal investigator, CovanceMuna Albayaty, MBChB,FFPM,MSc, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293654
- Sponsor's protocol ID
- MB02 A 02 17
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2017
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US Licenced Avastin® and EU Approved Avastin® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03293654
- Acronym / sponsor ID
- MB02 A 02 17
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the Pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU 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.
Detailed description
The primary PK parameters are Cmax and AUC(0-∞). The PK parameters for 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 will be derived for the comparisons of the PK parameters as follows:
- MB02 versus EU Avastin®
- MB02 versus US Avastin®
- EU Avastin® versus US Avastin®
PK similarity will be achieved if the 90% confidence intervals (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 versus EU-approved Avastin®; MB02 versus US-licenced Avastin®; and EU-approved Avastin® versus US-licenced 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 (CTCAE) version 4.03. 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). All safety data will be listed and summarised as appropriate
Immunogenicity data (overall anti-drug antibody [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®, or US Avastin® (Day 1) and at scheduled postdose assessments will be presented by treatment arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MB02 (Bevacizumab Biosimilar) | Experimental | Drug: MB02Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. |
| US licenced Avastin® | Active comparator | Drug: US licenced Avastin®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
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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 60 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 nonhaemolytic 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.
Key exclusion criteria (27 listed)
- 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.
- 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.
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 |
|---|---|---|
| MB02Also: MB02 (Bevacizumab Biosimilar)Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion. | Drug | MB02 (Bevacizumab Biosimilar) |
| US licenced Avastin®Also: Bevacizumab (United States)Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion. | Drug | US licenced Avastin® |
| EU approved Avastin®Also: Bevacizumab (European Union)Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion. | Drug | EU approved Avastin® |
Primary outcome
Cmax: Maximum Observed Serum Concentration
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of Cmax) to establish bioequivalence between the 3 study arms. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric LS means ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.
AUC(0-∞); Area Under the Serum Concentration-time Curve From Time Zero to Infinity
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of AUC[0-∞]) to establish bioequivalence between the 3 study arms. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric least square means (GLSM) ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.
6 secondary outcomes
Tmax: Time of Maximum Observed Serum Concentration
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
AUC(0-t) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Observable Concentration;
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
CL: Total Body Drug Clearance After IV Administration
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
t1/2: Apparent Serum Terminal Elimination Half-life
Time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.
Immunogenicity
Time frame: Day -1, Day 14, 28, 56, and 78
Safety (Incidence of Treatment-related Adverse Events Using CTCAE v4.03)
Time frame: Day 1 - Day 100
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.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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.
Sunu Valasseri, MBBS, MSc principal investigator
Covance
Muna Albayaty, MBChB,FFPM,MSc principal investigator
Parexel
2 sites 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, US licenced Avastin® and EU approved Avastin® in people with Healthy Volunteers, run by mAbxience Research S.L. at 2 sites in United Kingdom.
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 22 inclusion and 27 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 2 sites in United Kingdom. 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 16 Jun 2020). 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?
Cmax: Maximum Observed Serum Concentration (time frame: Predose, 1.5 h after 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 42, Day 56, Day 78, and Day 100.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.