Healthy
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
Interventions
BIOLOGICALPen of SB5
BIOLOGICALPFS of SB5
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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 to 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 subject's last 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
| Measure | Time frame |
|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
| Maximum Serum Concentration (Cmax) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach Cmax (Tmax) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
Countries
Belgium, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pen of SB5 Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5 | 95 |
| PFS of SB5 PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5 | 95 |
| Total | 190 |
Baseline characteristics
| Characteristic | Pen of SB5 | PFS of SB5 | Total |
|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 10.58 | 30.5 years STANDARD_DEVIATION 11.41 | 30.8 years STANDARD_DEVIATION 10.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 92 Participants | 182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 177.63 cm STANDARD_DEVIATION 7.753 | 177.89 cm STANDARD_DEVIATION 7.814 | 177.76 cm STANDARD_DEVIATION 7.764 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 80 Participants | 158 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 86 Participants | 85 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 95 | 28 / 94 |
| serious Total, serious adverse events | 1 / 95 | 2 / 94 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pen of SB5 | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 2743.2 h·μg/mL | Standard Deviation 1081.76 |
| PFS of SB5 | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 2503.3 h·μg/mL | Standard Deviation 1043.69 |
Primary
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pen of SB5 | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 2329.2 h·μg/mL | Standard Deviation 733.3 |
| PFS of SB5 | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 2182.2 h·μg/mL | Standard Deviation 724.98 |
Primary
Maximum Serum Concentration (Cmax)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pen of SB5 | Maximum Serum Concentration (Cmax) | 3.803 μg/mL | Standard Deviation 1.0697 |
| PFS of SB5 | Maximum Serum Concentration (Cmax) | 3.673 μg/mL | Standard Deviation 0.881 |
Secondary
Time to Reach Cmax (Tmax)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pen of SB5 | Time to Reach Cmax (Tmax) | 168.000 h |
| PFS of SB5 | Time to Reach Cmax (Tmax) | 168.000 h |