A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
B538-07
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
2 other identifiers
interventional
362
1 country
8
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2014
Shorter than P25 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 13, 2015
April 1, 2015
6 months
September 9, 2014
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
maximal serum concentration (Cmax)
maximal serum concentration (Cmax)
Day 1 - Day 50
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
0-336 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf)
AUC extrapolated to infinity (AUC0inf)
Day 1 - Day 50
Secondary Outcomes (10)
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
Day 1- Day 71
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
Day 1- Day 71
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
Day 1 - Day 50
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
0-336 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
Day 1 - Day 50
- +5 more secondary outcomes
Study Arms (3)
PF-06410293
EXPERIMENTALAdalimumab-US
ACTIVE COMPARATORAdalimumab-EU
ACTIVE COMPARATORAdalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Interventions
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (8)
De La Pedraja Radiology Associates
Coral Gables, Florida, 33134, United States
SeaView Jacksonville
Jacksonville, Florida, 32256, United States
SeaView Research, Inc.
Miami, Florida, 33126, United States
SeaView Reseach Screening Office
Miami, Florida, 33134, 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
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 11, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 13, 2015
Record last verified: 2015-04