None listed
Conditions
Interventions
investigational material(s)
Generic name etc : MB02
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Sponsors
mAbxience Research S.L.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects with Body mass index (BMI) between =>18.5 to =50 and =<100 kg, at Screening 2) Systolic blood pressure =<140 mm Hg and diastolic blood pressure =<90 mm H g. 3) Computerized (12-lead) ECG recording without signs of clinically relevant pathology. 4) 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 laboratory values from study value. 5) Ability and willingness of accordance with limitation rules in the study period.
Exclusion criteria
Exclusion criteria: History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency 2) 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 3) 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 4) 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) 5) Any current or recent history of active infections, including localized infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence To demonstrate pharmacokinetic similarity, as primary assessed by the Area Under the Concentration-time curve extrapolated to infinity (AUC(0-inf)) between the two study arms, MB02 and EU-Avastin | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other - Evaluation and comparison of derived PK parameters not covered by the primary endpoints for MB02 and EU approved Avastin - To compare the safety profile of MB02 and EU approved Avastin - To compare the immunogenicity of MB02 and EU approved Avastin | — |
Countries
Japan
Outcome results
None listed