HealthyPhase 1NCT02144714

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

A Phase 1 study testing SB5, EU sourced Humira® and US sourced Humira® 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

Search all trials

Trial summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) 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?: SB5, EU sourced Humira® and US sourced Humira®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 189 participants
Where: 1 siteGermany
Study dates: May 2014to Sep 2014
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 subjects
Have 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 investigational product 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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration

Trial locations and contacts

1 site in 1 country.

Germany1 site

Samsung Investigational Site
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 Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.

Conditions: Healthy
Being tested: SB5, EU sourced Humira®, US sourced Humira®

What participants receive

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

SB5Biological
EU sourced Humira®Biological
US sourced Humira®Biological

Study groups in NCT02144714
Study group	Role	What they receive
SB5	Experimental	SB5, single dose of 40 mg via subcutaneous injection (study drug) Receives: Biological: SB5; Biological: EU sourced Humira®
EU sourced Humira®	Active comparator	EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) Receives: Biological: SB5; Biological: US sourced Humira®
US sourced Humira®	Active comparator	US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) Receives: Biological: EU sourced Humira®; Biological: US sourced Humira®

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 (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Measured: 0 to 1680 hours post-dose
Maximum Serum Concentration (Cmax)
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Measured: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Measured: 0 to 1680 hours post-dose

Secondary outcomes (1)

Time to Cmax (Tmax)
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Measured: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Timeline

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

May 2014Sep 2014

First posted22 May 2014 (estimated)
Study startMay 2014
Primary completionSep 2014
Study completionSep 2014

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: 189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144714
Sponsor's protocol ID: SB5-G11-NHV
Other IDs: 2013-005332-15
Status last verified: Oct 2018
First submitted: 20 May 2014
Last updated: 14 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
PubMed 33263165

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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. 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 Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects
ClinicalTrials.gov ID: NCT02144714
Acronym / sponsor ID: SB5-G11-NHV
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 189 participants (actual)
Lead sponsor: Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 22 May 2014 (estimated)
Results: Posted 21 Sep 2018

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 SB5 and Humira (EU sourced Humira® and US sourced Humira®) 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
SB5	Experimental	Biological: SB5, Biological: EU sourced Humira®SB5, single dose of 40 mg via subcutaneous injection (study drug)
EU sourced Humira®	Active comparator	Biological: SB5, Biological: US sourced Humira®EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
US sourced Humira®	Active comparator	Biological: EU sourced Humira®, Biological: US sourced Humira®US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy subjects
Have 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 investigational product 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
SB5	Biological	EU sourced Humira®, SB5
EU sourced Humira®	Biological	SB5, US sourced Humira®
US sourced Humira®	Biological	EU sourced Humira®, US sourced Humira®

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 0 to 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Maximum Serum Concentration (Cmax)
Time frame: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 0 to 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

1 secondary outcome

Time to Cmax (Tmax)
Time frame: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Results and safety

Results posted to the registry on 21 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SB5 (Proposed Adalimumab Biosimilar)	63	63
EU Sourced Humira®	63	63
US Sourced Humira®	63	63

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

Time frame: 0 to 1680 hours post-dose. Mean (Standard Deviation). Unit: μg·h/mL

Measure	SB5 (Proposed Adalimumab Biosimilar) n = 53	EU Sourced Humira® n = 61	US Sourced Humira® n = 57
Value	2405.6 (825.93)	2435.5 (915.66)	2422.6 (957.00)

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: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose. Mean (Standard Deviation). Unit: μg/mL

Measure	SB5 (Proposed Adalimumab Biosimilar) n = 53	EU Sourced Humira® n = 61	US Sourced Humira® n = 57
Value	3.365 (0.9796)	3.548 (1.1811)	3.488 (1.0779)

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

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

Time frame: 0 to 1680 hours post-dose. Mean (Standard Deviation). Unit: μg·h/mL

Measure	SB5 (Proposed Adalimumab Biosimilar) n = 53	EU Sourced Humira® n = 61	US Sourced Humira® n = 57
Value	2125.7 (689.92)	2096.0 (791.28)	2101.9 (795.56)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB5 (Proposed Adalimumab Biosimilar)	1 of 63 (1.6%)	29 of 63 (46%)	Not reported
EU Sourced Humira®	0 of 63 (0%)	17 of 63 (27%)	Not reported
US Sourced Humira®	1 of 63 (1.6%)	25 of 63 (39.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33263165Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 SB5, EU sourced Humira® and US sourced Humira® 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 14 Nov 2018. 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 Sep 2018). 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 1680 hours post-dose). 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 NCT02144714, 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 14 Nov 2018.