Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT01870986
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • PF-06410293 — BIOLOGICAL
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
  • Humira (adalimumab-EU) — BIOLOGICAL
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
  • Humira (adalimumab-US) — BIOLOGICAL
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Study Details

This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.

Key Dates

Start date
May 31, 2013
Status verified
Feb 2014
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: A
    PF-06410293
  • Active Comparator: B
    Adalimumab-EU
  • Active Comparator: C
    Adalimumab-US

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: Day 1 - Day 43 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteNew HavenConnecticut06511-

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By research site
Pfizer Investigational Site· New Haven, CT

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