jRCT2080225005CompletedPhase 1
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
mAbxience Research S.L.1 site48 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- AUC(0-inf)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Randomized (1:1), double blind, single-dose, two arms, parallel phase 1 study
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 20age old over to 55age old under (—)
- Sex
- Male
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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