ICON Early Phase Services, LLC
San Antonio, Texas, 78209, United States
NCT Number: NCT02572245
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
Exclusion criteria
PF-06410293 40 mg administered subcutaneously by Prefilled syringe
PF-06410293 40 mg administered subcutaneously by prefilled pen
Time frame: Day 1 - Day 15
Time frame: Day 1-Day 15
Time frame: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device
Time frame: 1, 3, 8, 12 and 24 hours post injection
Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device
Time frame: Day 1 - Day 43
Time frame: Day 1 - Day 43
Time frame: Day 1 - Day 43
Time frame: Day 1 - Day 43
Time frame: Day 1 - Day 43
Time frame: Day 1 - Day 43
Pfizer
Industry
A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
Acronym: B538-05
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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