Status:
COMPLETED
A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
Lead Sponsor:
mAbxience Research S.L.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 ma...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2019
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03293654
Start Date
December 7 2017
End Date
May 29 2019
Last Update
March 23 2021
Active Locations (2)
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1
PAREXEL International - Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
2
Covance Clinical Research Unit Limited
Leeds, United Kingdom, LS2 9LH