A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/1/2014 |
| Start Date: | May 2013 |
| End Date: | November 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
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.
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.
Inclusion Criteria:
- Healthy female subjects of non-childbearing potential and healthy male subjects
(healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant infectious, hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, autoimmune, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at time of dosing).
- Previous exposure to a monoclonal antibody, or current use of other biologics.
- History of hypersensitivity reaction to inactive components of the study drugs or any
murine proteins or anaphylactic reactions to therapeutic drugs.
- History of tuberculosis (TB) or a positive latent TB test at Screening.
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