A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Pfizer
Study ID
NCT02237729
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • PF-06410293 — BIOLOGICAL
    PF-06410293 will be administered as a single 40 mg, subcutaneous dose
  • Adalimumab-US — BIOLOGICAL
    Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
  • Adalimumab-EU — BIOLOGICAL
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Study Details

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

Key Dates

Start date
Sep 30, 2014
Status verified
Apr 2015
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
362 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: PF-06410293
  • Active Comparator: Adalimumab-US
  • Active Comparator: Adalimumab-EU
    Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Primary Outcome Measure

maximal serum concentration (Cmax) [ Time Frame: Day 1 - Day 50 ]

Locations (8)

FacilityCityStateZIPSite coordinators
De La Pedraja Radiology AssociatesCoral GablesFlorida33134-
SeaView JacksonvilleJacksonvilleFlorida32256-
SeaView Reseach Screening OfficeMiamiFlorida33134-
SeaView Research, Inc.MiamiFlorida33126-
SeaView Research, Inc. (Screening Office)MiamiFlorida33134-
Vince & Associates Clinical Research, Inc.Overland ParkKansas66211-
Vince & Associates Clinical Research, Inc.Overland ParkKansas66212-
Prism Research, LLCSaint PaulMinnesota55114-

Find similar trials in Coral Gables, FL

By research site
De La Pedraja Radiology Associates· Coral Gables, FLSeaView Jacksonville· Jacksonville, FLSeaView Reseach Screening Office· Miami, FLSeaView Research, Inc.· Miami, FLSeaView Research, Inc. (Screening Office)· Miami, FLVince & Associates Clinical Research, Inc.· Overland Park, KS

Related Studies