HealthyPhase 1NCT01865552

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

A Phase 1 study testing SB4, EU sourced Enbrel and US sourced Enbrel 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 and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects. 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?: SB4, EU sourced Enbrel and US sourced Enbrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteGermany
Study dates: May 2013to Aug 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects
Have a body weight between 60 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 TB.
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 first administration of IP.

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-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects

The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

Read the detailed description

Part A: Comparison between SB4 and EU sourced Enbrel
Part B: Comparison between SB4 and US sourced Enbrel
Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Conditions: Healthy
Being tested: SB4, EU sourced Enbrel, US sourced Enbrel
Keywords: Pharmacokinetics

What participants receive

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

SB4Biological
SC administration
EU sourced EnbrelBiological
SC administration
US sourced EnbrelBiological
SC administration

Study groups in NCT01865552
Study group	Role	What they receive
SB4 and EU sourced Enbrel in Part A	Experimental	SB4 followed by EU sourced Enbrel Receives: Biological: SB4; Biological: EU sourced Enbrel
EU sourced Enbrel and SB4 in Part A	Experimental	EU sourced Enbrel followed by SB4 Receives: Biological: SB4; Biological: EU sourced Enbrel
SB4 and US sourced Enbrel in Part B	Experimental	SB4 followed by US sourced Enbrel Receives: Biological: SB4; Biological: US sourced Enbrel
US sourced Enbrel and SB4 in Part B	Experimental	US sourced Enbrel followed by SB4 Receives: Biological: SB4; Biological: US sourced Enbrel
EU and US sourced Enbrel in Part C	Other	EU sourced Enbrel followed by US sourced Enbrel Receives: Biological: EU sourced Enbrel; Biological: US sourced Enbrel
US and EU sourced Enbrel in Part C	Other	US sourced Enbrel followed by EU sourced Enbrel Receives: Biological: EU sourced Enbrel; Biological: US sourced Enbrel

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)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Measured: 0 to 480 hours post-dose
Maximum Serum Concentration (Cmax)
pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
Measured: 0 to 480 hours post-dose

Secondary outcomes (2)

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Measured: 0 to 480 hours post-dose
Time to Cmax (Tmax)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Measured: 0 to 480 hours post-dose

Timeline

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

May 2013Aug 2013

First posted31 May 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionAug 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.
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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01865552
Sponsor's protocol ID: SB4-G11-NHV
Other IDs: 2012-004371-39
Status last verified: Jun 2019
First submitted: 27 May 2013
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01865552
Acronym / sponsor ID: SB4-G11-NHV
Conditions: Healthy
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 31 May 2013 (estimated)
Results: Posted 4 Jun 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 and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

Detailed description

Part A: Comparison between SB4 and EU sourced Enbrel
Part B: Comparison between SB4 and US sourced Enbrel
Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
SB4 and EU sourced Enbrel in Part A	Experimental	Biological: SB4, Biological: EU sourced EnbrelSB4 followed by EU sourced Enbrel
EU sourced Enbrel and SB4 in Part A	Experimental	Biological: SB4, Biological: EU sourced EnbrelEU sourced Enbrel followed by SB4
SB4 and US sourced Enbrel in Part B	Experimental	Biological: SB4, Biological: US sourced EnbrelSB4 followed by US sourced Enbrel
US sourced Enbrel and SB4 in Part B	Experimental	Biological: SB4, Biological: US sourced EnbrelUS sourced Enbrel followed by SB4
EU and US sourced Enbrel in Part C	Other	Biological: EU sourced Enbrel, Biological: US sourced EnbrelEU sourced Enbrel followed by US sourced Enbrel
US and EU sourced Enbrel in Part C	Other	Biological: EU sourced Enbrel, Biological: US sourced EnbrelUS sourced Enbrel followed by EU sourced Enbrel

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 a body weight between 60 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 TB.
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
SB4SC administration	Biological	EU sourced Enbrel and SB4 in Part A, SB4 and EU sourced Enbrel in Part A, SB4 and US sourced Enbrel in Part B, US sourced Enbrel and SB4 in Part B
EU sourced EnbrelSC administration	Biological	EU and US sourced Enbrel in Part C, EU sourced Enbrel and SB4 in Part A, SB4 and EU sourced Enbrel in Part A, US and EU sourced Enbrel in Part C
US sourced EnbrelSC administration	Biological	EU and US sourced Enbrel in Part C, SB4 and US sourced Enbrel in Part B, US and EU sourced Enbrel in Part C, US sourced Enbrel and SB4 in Part B

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 0 to 480 hours post-dose
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Maximum Serum Concentration (Cmax)
Time frame: 0 to 480 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.

2 secondary outcomes

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 0 to 480 hours post-dose
Time to Cmax (Tmax)
Time frame: 0 to 480 hours post-dose

Results and safety

Results posted to the registry on 4 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
SB4 and EU Sourced Enbrel in Part A	23	22
EU Sourced Enbrel and SB4 in Part A	23	23
SB4 and US Sourced Enbrel in Part B	23	23
US Sourced Enbrel and SB4 in Part B	23	22
EU and US Sourced Enbrel in Part C	23	20
US and EU Sourced Enbrel in Part C	23	22

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

Time frame: 0 to 480 hours post-dose. Mean (Standard Deviation). Unit: µg·h/mL

Measure	SB4 in Part A n = 42	EU Sourced Enbrel in Part A n = 42	SB4 in Part B n = 44	US Sourced Enbrel in Part B n = 44	EU Sourced Enbrel in Part C n = 42	US Sourced Enbrel in Part C n = 42
Value	769.069 (243.9039)	771.680 (226.2874)	834.680 (242.7652)	810.054 (195.9770)	790.110 (274.2535)	768.228 (238.1251)

Population analysed: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.

Primary outcome: Maximum Serum Concentration (Cmax)

Time frame: 0 to 480 hours post-dose. Mean (Standard Deviation). Unit: μg/mL

Measure	SB4 in Part A n = 42	EU Sourced Enbrel in Part A n = 42	SB4 in Part B n = 44	US Sourced Enbrel in Part B n = 44	EU Sourced Enbrel in Part C n = 42	US Sourced Enbrel in Part C n = 42
Value	3.607 (1.4298)	3.435 (1.2390)	3.869 (1.3251)	3.613 (1.0252)	3.720 (1.5444)	3.575 (1.4833)

Population analysed: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB4 in Part A	0 of 46 (0%)	18 of 46 (39.1%)	0 of 46
EU Sourced Enbrel in Part A	0 of 46 (0%)	16 of 46 (34.8%)	0 of 46
SB4 in Part B	0 of 46 (0%)	23 of 46 (50%)	0 of 46
US Sourced Enbrel in Part B	0 of 46 (0%)	20 of 46 (43.5%)	0 of 46
EU Sourced Enbrel in Part C	0 of 46 (0%)	17 of 46 (37%)	0 of 46
US Sourced Enbrel in Part C	0 of 46 (0%)	14 of 46 (30.4%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 SB4, EU sourced Enbrel and US sourced Enbrel 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 4 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 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 4 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 480 hours post-dose). The study lists 2 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 NCT01865552.

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 4 Jun 2019.