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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B537-01 |
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In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A = PF-06438179 | Experimental |
| |
| B = Infliximab-EU | Active Comparator |
| |
| C = Infliximab-US | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06438179 | Biological | Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 - Day 57 | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) | Day 1 - Day 57 | |
| Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) | Day 1 - Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Clearance (CL) | Day 1 - Day 57 | |
| Terminal Disposition Half-Life (t1/2) | Day 1 - Day 57 | |
| Volume of Distribution at Steady State (Vss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29504427 | Derived | Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000630865 | GP1111 |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Remicade | Biological | Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 |
|
|
| Remicade | Biological | Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 |
|
|
| Day 1 - Day 57 |
| Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab) | Day 1 - LSLV or Day 85 whichever occurs later |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |