HealthyPhase 1NCT02453672

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

A Phase 1 study testing SB8, EU sourced Avastin® and US Sourced Avastin® in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SB8, EU sourced Avastin® and US Sourced Avastin®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteBelgium
Study dates: Apr 2015to Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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 locations and contacts

1 site in 1 country.

Belgium1 site

Samsung Investigational Site
Antwerp

Other trials in Belgium

About this study

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

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

Read the 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

Conditions: Healthy
Being tested: SB8, EU sourced Avastin®, US Sourced Avastin®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SB8Biological
SB8, proposed bevacizumab biosimilar
EU sourced Avastin®Biological
EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
US Sourced Avastin®Biological
US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Study groups in NCT02453672
Study group	Role	What they receive
SB8	Experimental	SB8, single dose of 3 mg/kg, IV infusion Receives: Biological: SB8
EU Sourced Avastin®	Active comparator	EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion Receives: Biological: EU sourced Avastin®
US Sourced Avastin®	Active comparator	US Sourced Avastin®, single dose of 3 mg/kg, IV infusion Receives: Biological: US Sourced Avastin®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 0 to 2016 hours after start of infusion

Secondary outcomes (1)

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.
Measured: 0 to 2016 hours after start of infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Sep 2015

First posted25 May 2015 (estimated)
Study startApr 2015
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02453672
Sponsor's protocol ID: SB8-G11-NHV
Other IDs: 2015-001026-41, 2015
Status last verified: Feb 2019
First submitted: 21 May 2015
Last updated: 3 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 32949267

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02453672
Acronym / sponsor ID: SB8-G11-NHV
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 25 May 2015 (estimated)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SB8	Experimental	Biological: SB8SB8, single dose of 3 mg/kg, IV infusion
EU Sourced Avastin®	Active comparator	Biological: EU sourced Avastin®EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
US Sourced Avastin®	Active comparator	Biological: US Sourced Avastin®US Sourced Avastin®, single dose of 3 mg/kg, IV infusion

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SB8SB8, proposed bevacizumab biosimilar	Biological	SB8
EU sourced Avastin®EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)	Biological	EU Sourced Avastin®
US Sourced Avastin®US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)	Biological	US Sourced Avastin®

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 0 to 2016 hours after start of infusion
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.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 0 to 2016 hours after start of infusion
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.
Maximum Serum Concentration (Cmax)
Time frame: 0 to 2016 hours after start of infusion
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.

1 secondary outcome

Time to Reach Cmax (Tmax)
Time frame: 0 to 2016 hours after start of infusion

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SB8 (Proposed Bevacizumab Biosimilar)	40	37
EU Sourced Avastin®	40	38
US Sourced Avastin®	39	38

Primary outcome: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)

Time frame: 0 to 2016 hours after start of infusion. Mean (Standard Deviation). Unit: h·μg/mL

Measure	SB8 (Proposed Bevacizumab Biosimilar) n = 38	EU Sourced Avastin® n = 38	US Sourced Avastin® n = 38
Value	25354.4 (4833.10)	28896.8 (6221.62)	28684.8 (5425.14)

Population analysed: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

Time frame: 0 to 2016 hours after start of infusion. Mean (Standard Deviation). Unit: h·μg/mL

Measure	SB8 (Proposed Bevacizumab Biosimilar) n = 38	EU Sourced Avastin® n = 38	US Sourced Avastin® n = 38
Value	24199.2 (4367.53)	27342.2 (5374.53)	27177.9 (4770.93)

Population analysed: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.

Primary outcome: Maximum Serum Concentration (Cmax)

Time frame: 0 to 2016 hours after start of infusion. Mean (Standard Deviation). Unit: μg/mL

Measure	SB8 (Proposed Bevacizumab Biosimilar) n = 38	EU Sourced Avastin® n = 38	US Sourced Avastin® n = 38
Value	76.259 (14.6999)	76.059 (11.7053)	76.485 (16.9916)

Population analysed: Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB8 (Proposed Bevacizumab Biosimilar)	1 of 40 (2.5%)	20 of 40 (50%)	0 of 40
EU Sourced Avastin®	0 of 40 (0%)	15 of 40 (37.5%)	0 of 40
US Sourced Avastin®	0 of 39 (0%)	21 of 39 (53.8%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32949267Shin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB8, EU sourced Avastin® and US Sourced Avastin® in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) (time frame: 0 to 2016 hours after start of infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02453672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.