A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: PF-06410293 (Biological); Adalimumab-US (Biological); Adalimumab-EU (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is a Phase 1, double blind (sponsor open), randomized (1: 1:1), parallel group, 3 arm,
single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and
EU administered subcutaneously (SC) to healthy male and female volunteers
Clinical Details
Official title: Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: maximal serum concentration (Cmax)area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] AUC extrapolated to infinity (AUC0inf)
Secondary outcome: Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parametersIncidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US time to reach the maximum concentration (Tmax) Apparent clearance (CL/F) Apparent volume of distribution (Vz/F) Terminal half-life (T1/2)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 and 45 years, inclusive.
Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, complete physical examination including blood pressure and heart
rate measurement, 12 lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 19. 0 to 30. 5 kg/m2; and a total body weight >60 kg (132
lbs).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, general
infections, heart failure, malignancy, or other clinically significant abnormalities
taken at Screening or within 24 weeks prior to Day 1 and read by a qualified
radiologist.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
autoimmune, or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell
carcinoma of the skin.
Locations and Contacts
De La Pedraja Radiology Associates, Coral Gables, Florida 33134, United States
SeaView Jacksonville, Jacksonville, Florida 32256, United States
SeaView Reseach Screening Office, Miami, Florida 33134, United States
SeaView Research, Inc., Miami, Florida 33126, United States
SeaView Research, Inc. (Screening Office), Miami, Florida 33134, United States
Vince & Associates Clinical Research, Inc., Overland Park, Kansas 66211, United States
Vince & Associates Clinical Research, Inc., Overland Park, Kansas 66212, United States
Prism Research, LLC, Saint Paul, Minnesota 55114, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2014
Last updated: April 10, 2015
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