Healthy
Conditions
Keywords
Pharmacokinetics
Brief 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.
Interventions
BIOLOGICALSB2
IV infusion
BIOLOGICALEU Remicade
IV infusion
BIOLOGICALUS Remicade
IV infusion
Sponsors
Samsung Bioepis Co., Ltd.
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 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 71 days |
| Maximum Serum Concentration (Cmax) | 71 days |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 71 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cmax (Tmax) | 71 days |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB2 (Proposed Infliximab Biosimilar) SB2 (Study drug)
SB2: IV infusion | 53 |
| EU Remicade EU sourced Remicade (Reference drug)
EU Remicade: IV infusion | 53 |
| US Remicade US sourced Remicade (Reference drug)
US Remicade: IV infusion | 53 |
| Total | 159 |
Baseline characteristics
| Characteristic | SB2 (Proposed Infliximab Biosimilar) | EU Remicade | US Remicade | Total |
|---|---|---|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 9.67 | 40.3 years STANDARD_DEVIATION 9.72 | 39.4 years STANDARD_DEVIATION 9.87 | 40.1 years STANDARD_DEVIATION 9.71 |
| BMI | 24.56 kg/m2 STANDARD_DEVIATION 2.078 | 25.39 kg/m2 STANDARD_DEVIATION 2.092 | 24.79 kg/m2 STANDARD_DEVIATION 2.058 | 24.91 kg/m2 STANDARD_DEVIATION 2.092 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 52 Participants | 52 Participants | 155 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 49 Participants | 51 Participants | 50 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 14 / 53 | 11 / 53 | 13 / 53 |
| serious Total, serious adverse events | 2 / 53 | 0 / 53 | 0 / 53 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 71 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB2 (Proposed Infliximab Biosimilar) | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 38702.8145 h·μg/mL | Standard Deviation 11113.62172 |
| EU Remicade | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 39359.7493 h·μg/mL | Standard Deviation 12332.41615 |
| US Remicade | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 39270.1707 h·μg/mL | Standard Deviation 10064.08853 |
Primary
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 71 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB2 (Proposed Infliximab Biosimilar) | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 36862.4180 h·μg/mL | Standard Deviation 9132.75342 |
| EU Remicade | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 37022.3524 h·μg/mL | Standard Deviation 9398.42182 |
| US Remicade | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 37367.5577 h·μg/mL | Standard Deviation 8332.05331 |
Primary
Maximum Serum Concentration (Cmax)
Time frame: 71 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB2 (Proposed Infliximab Biosimilar) | Maximum Serum Concentration (Cmax) | 126.9975 μg/mL | Standard Deviation 16.89586 |
| EU Remicade | Maximum Serum Concentration (Cmax) | 126.2377 μg/mL | Standard Deviation 17.88151 |
| US Remicade | Maximum Serum Concentration (Cmax) | 129.1508 μg/mL | Standard Deviation 18.75573 |
Secondary
Time to Cmax (Tmax)
Time frame: 71 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB2 (Proposed Infliximab Biosimilar) | Time to Cmax (Tmax) | 2.9294 hour | Standard Deviation 1.11529 |
| EU Remicade | Time to Cmax (Tmax) | 2.5824 hour | Standard Deviation 0.9595 |
| US Remicade | Time to Cmax (Tmax) | 2.7591 hour | Standard Deviation 1.03184 |