NCT02453672

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

May 21, 2015

Results QC Date

October 9, 2018

Last Update Submit

February 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Time to Reach Cmax (Tmax)

    0 to 2016 hours after start of infusion

Study Arms (3)

SB8

EXPERIMENTAL

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

Biological: SB8

EU Sourced Avastin®

ACTIVE COMPARATOR

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

Biological: EU sourced Avastin®

US Sourced Avastin®

ACTIVE COMPARATOR

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

Biological: US Sourced Avastin®

Interventions

SB8BIOLOGICAL

SB8, proposed bevacizumab biosimilar

SB8
EU sourced Avastin®BIOLOGICAL

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

EU Sourced Avastin®
US Sourced Avastin®BIOLOGICAL

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

US Sourced Avastin®

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Investigational Site

Antwerp, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 32949267DERIVED

Results Point of Contact

Title
Director of Clinical Development
Organization
Samsung Bioepis
sbregistry@samsung.com
+82 31 8061 4534

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 25, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Locations

BE(1)