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

JAPIC ID: JapicCTI-205096

Registered date:07/01/2020

Basic Information

• Recruitment status: complete
• Health condition(s) or Problem(s) studied: -
• Date of first enrollment: 19/9/2019
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: INTERVENTIONAL

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 Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: 20
• Age maximum: 55
• Gender: Male

Include criteria

1) 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 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.

Related Information

• Primary Sponsor: mAbxience Research S.L.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -