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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144714
Enrollment
189
Registered
2014-05-22
Start date
2014-05-31
Completion date
2014-09-30
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

BIOLOGICALSB5
BIOLOGICALEU sourced Humira®
BIOLOGICALUS sourced Humira®

Sponsors

Samsung Bioepis Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects * Have a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)0 to 1680 hours post-dosepre-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)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-dosepre-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)0 to 1680 hours post-dosepre-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

Secondary

MeasureTime frameDescription
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-dosepre-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

Countries

Germany

Participant flow

Participants by arm

ArmCount
SB5 (Proposed Adalimumab Biosimilar)
SB5, single dose of 40 mg via subcutaneous injection (study drug) SB5 EU sourced Humira®
63
EU Sourced Humira®
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) SB5 US sourced Humira®
63
US Sourced Humira®
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) EU sourced Humira® US sourced Humira®
63
Total189

Baseline characteristics

CharacteristicSB5 (Proposed Adalimumab Biosimilar)EU Sourced Humira®US Sourced Humira®Total
Age, Continuous38.3 years
STANDARD_DEVIATION 9.55
40.2 years
STANDARD_DEVIATION 11.06
40.0 years
STANDARD_DEVIATION 10.94
39.5 years
STANDARD_DEVIATION 10.52
BMI (kg/m^2)24.98 kg/m^2
STANDARD_DEVIATION 2.301
24.82 kg/m^2
STANDARD_DEVIATION 1.823
24.97 kg/m^2
STANDARD_DEVIATION 1.959
24.93 kg/m^2
STANDARD_DEVIATION 2.028
Height (cm)177.8 cm
STANDARD_DEVIATION 6.72
177.5 cm
STANDARD_DEVIATION 6.34
177.0 cm
STANDARD_DEVIATION 6.68
177.4 cm
STANDARD_DEVIATION 6.56
Race/Ethnicity, Customized
Race
Asian
0 Participants2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Race
Black or African American
2 Participants0 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race
Mixed
0 Participants1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
White
61 Participants60 Participants62 Participants183 Participants
Sex: Female, Male
Female
4 Participants5 Participants6 Participants15 Participants
Sex: Female, Male
Male
59 Participants58 Participants57 Participants174 Participants
Weight (kg)78.83 kg
STANDARD_DEVIATION 7.163
78.19 kg
STANDARD_DEVIATION 6.388
78.12 kg
STANDARD_DEVIATION 6.458
78.38 kg
STANDARD_DEVIATION 6.651

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
29 / 6317 / 6325 / 63
serious
Total, serious adverse events
1 / 630 / 631 / 63

Outcome results

Primary

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

Time frame: 0 to 1680 hours post-dose

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

ArmMeasureValue (MEAN)Dispersion
SB5 (Proposed Adalimumab Biosimilar)Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)2405.6 μg·h/mLStandard Deviation 825.93
EU Sourced Humira®Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)2435.5 μg·h/mLStandard Deviation 915.66
US Sourced Humira®Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)2422.6 μg·h/mLStandard Deviation 957
Primary

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

Time frame: 0 to 1680 hours post-dose

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

ArmMeasureValue (MEAN)Dispersion
SB5 (Proposed Adalimumab Biosimilar)Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)2125.7 μg·h/mLStandard Deviation 689.92
EU Sourced Humira®Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)2096.0 μg·h/mLStandard Deviation 791.28
US Sourced Humira®Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)2101.9 μg·h/mLStandard Deviation 795.56
Primary

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

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

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

ArmMeasureValue (MEAN)Dispersion
SB5 (Proposed Adalimumab Biosimilar)Maximum Serum Concentration (Cmax)3.365 μg/mLStandard Deviation 0.9796
EU Sourced Humira®Maximum Serum Concentration (Cmax)3.548 μg/mLStandard Deviation 1.1811
US Sourced Humira®Maximum Serum Concentration (Cmax)3.488 μg/mLStandard Deviation 1.0779
Secondary

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

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

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

ArmMeasureValue (MEAN)Dispersion
SB5 (Proposed Adalimumab Biosimilar)Time to Cmax (Tmax)165.962 hStandard Deviation 89.2503
EU Sourced Humira®Time to Cmax (Tmax)149.715 hStandard Deviation 76.6421
US Sourced Humira®Time to Cmax (Tmax)166.456 hStandard Deviation 79.9227

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026