Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005306-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB2 | Experimental | SB2 (Study drug) |
|
| EU Remicade | Active Comparator | EU sourced Remicade (Reference drug) |
|
| US Remicade | Active Comparator | US sourced Remicade (Reference drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB2 | Biological | IV infusion |
| |
| EU Remicade |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) | 71 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr, M.D., Ph.D. | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26577771 | Derived | Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SB2 (Proposed Infliximab Biosimilar) | SB2 (Study drug) SB2: IV infusion |
| FG001 | EU Remicade | EU sourced Remicade (Reference drug) EU Remicade: IV infusion |
| FG002 | US Remicade | US sourced Remicade (Reference drug) US Remicade: IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB2 (Proposed Infliximab Biosimilar) | SB2 (Study drug) SB2: IV infusion |
| BG001 | EU Remicade | EU sourced Remicade (Reference drug) EU Remicade: IV infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | Posted | Mean | Standard Deviation | h·μg/mL | 71 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB2 (Proposed Infliximab Biosimilar) | SB2 (Study drug) SB2: IV infusion | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Borrelia infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd. | +82 31 8061 4534 | sbregistry@samsung.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
IV infusion |
|
| US Remicade | Biological | IV infusion |
|
| BG002 | US Remicade | US sourced Remicade (Reference drug) US Remicade: IV infusion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Maximum Serum Concentration (Cmax) | Posted | Mean | Standard Deviation | μg/mL | 71 days |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Posted | Mean | Standard Deviation | h·μg/mL | 71 days |
|
|
|
| Secondary | Time to Cmax (Tmax) | Posted | Mean | Standard Deviation | hour | 71 days |
|
|
|
| 53 |
| 2 |
| 53 |
| 14 |
| 53 |
| EG001 | EU Remicade | EU sourced Remicade (Reference drug) EU Remicade: IV infusion | 0 | 53 | 0 | 53 | 11 | 53 |
| EG002 | US Remicade | US sourced Remicade (Reference drug) US Remicade: IV infusion | 0 | 53 | 0 | 53 | 13 | 53 |
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Renal cyst ruptured | Renal and urinary disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided