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

NCT01870986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2014-02-14

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

PF-06410293

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

BIOLOGICAL

Humira (adalimumab-EU)

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

BIOLOGICAL

Humira (adalimumab-US)

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870986 on ClinicalTrials.gov