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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B538-01 |
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This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | PF-06410293 |
|
| B | Active Comparator | Adalimumab-EU |
|
| C | Active Comparator | Adalimumab-US |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06410293 | Biological | 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 - Day 43 | |
| Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast) | Day 1 - Day 43 | |
| Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf) | Day 1 - Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) | Day 1 - Day 71 | |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Day 1- Day 43 | |
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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 | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000631044 | PF-06410293 |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Humira (adalimumab-EU) | Biological | 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. |
|
|
| Humira (adalimumab-US) | Biological | 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. |
|
|
| Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing |
| Day 1- Day 43 |
| Systemic Clearance (CL) | Day 1- Day 43 |
| Serum Decay Half-Life (t1/2) | Serum decay half-life is teh time for the serum concentration to decrease by one half | Day 1- Day 43 |
| Brussels |
| B-1070 |
| Belgium |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |