Healthy
Conditions
Keywords
Pharmacokinetics
Brief summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Interventions
BIOLOGICALSB3
BIOLOGICALEU sourced Herceptin®
BIOLOGICALUS sourced Herceptin®
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects * Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.
Exclusion criteria
* history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies. * history of and/or current cardiac disease * previously received any monoclonal antibody or fusion protein. * history of cancer including lymphoma, leukaemia and skin cancer. * Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of 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) | 57 days |
| Maximum Serum Concentration (Cmax) | 57 days |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 57 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cmax (Tmax) | 57 days |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB3 (Proposed Trastuzumab Biosimilar) SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3 | 36 |
| EU Sourced Herceptin® EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin® | 37 |
| US Sourced Herceptin® US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin® | 36 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | SB3 (Proposed Trastuzumab Biosimilar) | EU Sourced Herceptin® | US Sourced Herceptin® | Total |
|---|---|---|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 10.29 | 39.3 years STANDARD_DEVIATION 10.8 | 38.7 years STANDARD_DEVIATION 11.4 | 38.8 years STANDARD_DEVIATION 10.75 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 36 Participants | 37 Participants | 36 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 25 / 36 | 23 / 36 | 25 / 36 |
| serious Total, serious adverse events | 1 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 57 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB3 (Proposed Trastuzumab Biosimilar) | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 34783.4 µg·h/mL | Standard Deviation 5614.13 |
| EU Sourced Herceptin® | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 35889.9 µg·h/mL | Standard Deviation 5761.37 |
| US Sourced Herceptin® | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 37370.3 µg·h/mL | Standard Deviation 5620.05 |
Primary
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 57 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB3 (Proposed Trastuzumab Biosimilar) | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 34320.8 µg·h/mL | Standard Deviation 5349.12 |
| EU Sourced Herceptin® | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 35367.5 µg·h/mL | Standard Deviation 5524.09 |
| US Sourced Herceptin® | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 36690.4 µg·h/mL | Standard Deviation 5341.68 |
Primary
Maximum Serum Concentration (Cmax)
Time frame: 57 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB3 (Proposed Trastuzumab Biosimilar) | Maximum Serum Concentration (Cmax) | 154.224 µg/mL | Standard Deviation 28.0068 |
| EU Sourced Herceptin® | Maximum Serum Concentration (Cmax) | 153.479 µg/mL | Standard Deviation 24.7249 |
| US Sourced Herceptin® | Maximum Serum Concentration (Cmax) | 155.513 µg/mL | Standard Deviation 25.5812 |
Secondary
Time to Cmax (Tmax)
Time frame: 57 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SB3 (Proposed Trastuzumab Biosimilar) | Time to Cmax (Tmax) | 4.691 hour | Standard Deviation 15.6597 |
| EU Sourced Herceptin® | Time to Cmax (Tmax) | 3.529 hour | Standard Deviation 7.6948 |
| US Sourced Herceptin® | Time to Cmax (Tmax) | 2.799 hour | Standard Deviation 3.7569 |