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
- Conditions
- -
- Registration Number
- jRCT2080225005
- Lead Sponsor
- mAbxience Research S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 48
- Subjects with Body mass index (BMI) between =>18.5 to =<28 kg/m2 and total body weight between =>50 and =<100 kg, at Screening
- Systolic blood pressure =<140 mm Hg and diastolic blood pressure =<90 mm H g.
- Computerized (12-lead) ECG recording without signs of clinically relevant pathology.
- 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.
- Ability and willingness of accordance with limitation rules in the study period.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Randomized (1:1), double blind, single-dose, two arms, parallel phase 1 study
- Primary Outcome Measures
Name Time Method AUC(0-inf) 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
Location not specified
Japan