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JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-205096

Registered date:07/01/2020

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

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studied-
Date of first enrollment19/9/2019
Target sample size48
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : MB02 INN of the intervention : - Dosage And administration of the intervention : 3 mg/kg, administered as a 90 minute IV infusion Control intervention name : Bevacizuma INN of the control intervention : Bevacizuma Dosage And administration of the control intervention : 3 mg/kg, administered as a 90 minute IV infusion

Outcome(s)

Primary Outcomebioequivalence 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 Outcomesafety, 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

Key inclusion & exclusion criteria

Age minimum20
Age maximum55
GenderMale
Include criteria1) Subjects with Body mass index (BMI) between =>18.5 to =<28 kg/m2 and total body weight between =>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.
Exclude criteriaHistory 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.

Related Information

Contact

public contact
Name Syneos Health Clinical K.K. Clinical Solutions Hiroaki KITAJIMA
Address 2-1-3 Nihonbashi, Chuo-ku, Tokyo 103-0027 JAPAN
Telephone
E-mail Hiroaki.Kitajima@inventivhealth.com
Affiliation
scientific contact
Name Syneos Health Clinical K.K. Clinical Solutions Hiroaki KITAJIMA
Address 2-1-3 Nihonbashi, Chuo-ku, Tokyo 103-0027 JAPAN
Telephone
E-mail Hiroaki.Kitajima@inventivhealth.com
Affiliation