HealthyPhase 1NCT01922336

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

A Phase 1 study testing SB2, EU Remicade and US Remicade in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.

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

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SB2, EU Remicade and US Remicade
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 1 siteGermany
Study dates: Jul 2013to Oct 2013
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female subjects of non-childbearing potential and healthy male subjects
Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Who cannot join

history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
active or latent Tuberculosis or who have a history of Tuberculosis.
history of invasive systemic fungal infections or other opportunistic infections
systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
serious infection associated with hospitalisation and/or which required intravenous antibiotics
history of and/or current cardiac disease
have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Parexel International GmbH
Berlin

Other trials in Germany

About this study

Official title: A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Conditions: Healthy
Being tested: SB2, EU Remicade, US Remicade
Keywords: Pharmacokinetics

What participants receive

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

SB2Biological
IV infusion
EU RemicadeBiological
IV infusion
US RemicadeBiological
IV infusion

Study groups in NCT01922336
Study group	Role	What they receive
SB2	Experimental	SB2 (Study drug) Receives: Biological: SB2
EU Remicade	Active comparator	EU sourced Remicade (Reference drug) Receives: Biological: EU Remicade
US Remicade	Active comparator	US sourced Remicade (Reference drug) Receives: Biological: US Remicade

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)
Measured: 71 days
Maximum Serum Concentration (Cmax)
Measured: 71 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Measured: 71 days

Secondary outcomes (1)

Time to Cmax (Tmax)
Measured: 71 days

Timeline

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

Jul 2013Oct 2013

First posted14 Aug 2013 (estimated)
Study startJul 2013
Primary completionOct 2013
Study completionOct 2013

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922336
Sponsor's protocol ID: SB2-G11-NHV
Other IDs: 2012-005306-22
Status last verified: Oct 2018
First submitted: 12 Aug 2013
Last updated: 21 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5.
PubMed 26577771

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 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
ClinicalTrials.gov ID: NCT01922336
Acronym / sponsor ID: SB2-G11-NHV
Conditions: Healthy
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Posted 21 Feb 2019

Clinical summary

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

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
SB2	Experimental	Biological: SB2SB2 (Study drug)
EU Remicade	Active comparator	Biological: EU RemicadeEU sourced Remicade (Reference drug)
US Remicade	Active comparator	Biological: US RemicadeUS sourced Remicade (Reference drug)

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy female subjects of non-childbearing potential and healthy male subjects
Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Key exclusion criteria (8 listed)

history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
active or latent Tuberculosis or who have a history of Tuberculosis.
history of invasive systemic fungal infections or other opportunistic infections
systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
serious infection associated with hospitalisation and/or which required intravenous antibiotics

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
SB2IV infusion	Biological	SB2
EU RemicadeIV infusion	Biological	EU Remicade
US RemicadeIV infusion	Biological	US Remicade

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 71 days
Maximum Serum Concentration (Cmax)
Time frame: 71 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 71 days

1 secondary outcome

Time to Cmax (Tmax)
Time frame: 71 days

Results and safety

Results posted to the registry on 21 Feb 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
SB2 (Proposed Infliximab Biosimilar)	53	53
EU Remicade	53	53
US Remicade	53	53

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

Time frame: 71 days. Mean (Standard Deviation). Unit: h·μg/mL

Measure	SB2 (Proposed Infliximab Biosimilar) n = 51	EU Remicade n = 53	US Remicade n = 53
Value	38702.8145 (11113.62172)	39359.7493 (12332.41615)	39270.1707 (10064.08853)

Primary outcome: Maximum Serum Concentration (Cmax)

Time frame: 71 days. Mean (Standard Deviation). Unit: μg/mL

Measure	SB2 (Proposed Infliximab Biosimilar) n = 51	EU Remicade n = 53	US Remicade n = 53
Value	126.9975 (16.89586)	126.2377 (17.88151)	129.1508 (18.75573)

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

Time frame: 71 days. Mean (Standard Deviation). Unit: h·μg/mL

Measure	SB2 (Proposed Infliximab Biosimilar) n = 51	EU Remicade n = 53	US Remicade n = 53
Value	36862.4180 (9132.75342)	37022.3524 (9398.42182)	37367.5577 (8332.05331)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB2 (Proposed Infliximab Biosimilar)	2 of 53 (3.8%)	14 of 53 (26.4%)	0 of 53
EU Remicade	0 of 53 (0%)	11 of 53 (20.8%)	0 of 53
US Remicade	0 of 53 (0%)	13 of 53 (24.5%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26577771Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5.

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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.

Rainard Fuhr, M.D., Ph.D. principal investigator

Parexel

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 SB2, EU Remicade and US Remicade in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.

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 21 Feb 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 Germany. 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 21 Feb 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: 71 days). 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 NCT01922336, 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 21 Feb 2019.