Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

Samsung

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: SB8; Biological: US Sourced Avastin®; Biological: EU sourced Avastin®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453672

2015-001026-41 (EudraCT Number)

SB8-G11-NHV

Details and patient eligibility

About

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

Full description

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects

Enrollment: 119 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects
• Have body weight between 65.0-90.0 kg (inclusive) and body mass index between 20.0-29.9 kg/m2 (inclusive)

Exclusion criteria

• Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of the excipients
• Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies
• Have a history of arterial thromboembolic events including cerebrovascular accidents, transient ischaemic attacks, and myocardial infarction
• Have a history of and/or current cardiac disease
• Have previously been exposed to vascular endothelial growth factor (VEGF) antibody, any other antibody, or protein targeting the VEGF receptor
• Have a history of cancer including lymphoma, leukaemia, and skin cancer.
• Have received live vaccine(s) within 30 days prior to Screening visit or who will require a vaccine(s) between Screening and the end of study visit
• Have taken medication with a half-life of > 24 hours within 30 days or 10 half-lives of the medication prior to the IP administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 3 patient groups

SB8

Experimental group

Description:

SB8, single dose of 3 mg/kg, IV infusion

Treatment:

Biological: SB8

EU Sourced Avastin®

Active Comparator group

Description:

EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion

Treatment:

Biological: EU sourced Avastin®

US Sourced Avastin®

Active Comparator group

Description:

US Sourced Avastin®, single dose of 3 mg/kg, IV infusion

Treatment:

Biological: US Sourced Avastin®