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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

NCT04238663

Healthy Volunteers

COMPLETED PHASE1

To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

NCT03247673

Healthy

COMPLETED PHASE1

A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

NCT03293654

Healthy Volunteers

COMPLETED PHASE1

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

NCT02469987

Healthy

COMPLETED PHASE1

A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers

NCT03576651

Healthy Male Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SB8

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

Group Type EXPERIMENTAL

SB8

Intervention Type BIOLOGICAL

SB8, proposed bevacizumab biosimilar

EU Sourced Avastin®

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

Group Type ACTIVE_COMPARATOR

EU sourced Avastin®

Intervention Type BIOLOGICAL

EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)

US Sourced Avastin®

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

Group Type ACTIVE_COMPARATOR

US Sourced Avastin®

Intervention Type BIOLOGICAL

US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB8

SB8, proposed bevacizumab biosimilar

Intervention Type BIOLOGICAL

EU sourced Avastin®

EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Intervention Type BIOLOGICAL

US Sourced Avastin®

US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes