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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453672
• Other study ID #: SB8-G11-NHV
• Secondary ID: 2015-001026-41
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2019
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• SB8
SB8, proposed bevacizumab biosimilar
• EU sourced Avastin®
EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
• US Sourced Avastin®
US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Locations

Country	Name	City	State
Belgium	Samsung Investigational Site	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.	0 to 2016 hours after start of infusion
Primary	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.	0 to 2016 hours after start of infusion
Primary	Maximum Serum Concentration (Cmax)	0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.	0 to 2016 hours after start of infusion
Secondary	Time to Reach Cmax (Tmax)	0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.	0 to 2016 hours after start of infusion