Clinical trial NCT02453672: Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 0 to 2016 hours after start of infusion
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 2016 hours after start of infusion
measure: Maximum Serum Concentration (Cmax)
timeFrame: 0 to 2016 hours after start of infusion
Secondary outcomes:
measure: Time to Reach Cmax (Tmax)
timeFrame: 0 to 2016 hours after start of infusion
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Samsung Investigational Site
Study officials:
References:
citation: Shin D, Lee YJ, Choi J, Lee D, Park M, Petkova M. A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers. Cancer Chemother Pharmacol. 2020 Oct;86(4):567-575. doi: 10.1007/s00280-020-04144-7. Epub 2020 Sep 19.