NCT01844804

Brief Summary

In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

April 29, 2013

Last Update Submit

January 6, 2014

Conditions

Healthy

Keywords

BioequivalenceBiosimilaritySimilarityPKPhase 1InfliximabHealthy VolunteersSingle-doseImmunology

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Serum Concentration (Cmax)

    Day 1 - Day 57

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)

    Day 1 - Day 57

  • Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)

    Day 1 - Day 57

Secondary Outcomes (4)

  • Systemic Clearance (CL)

    Day 1 - Day 57

  • Terminal Disposition Half-Life (t1/2)

    Day 1 - Day 57

  • Volume of Distribution at Steady State (Vss)

    Day 1 - Day 57

  • Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)

    Day 1 - LSLV or Day 85 whichever occurs later

Study Arms (3)

A = PF-06438179

EXPERIMENTAL
Biological: PF-06438179

B = Infliximab-EU

ACTIVE COMPARATOR
Biological: Remicade

C = Infliximab-US

ACTIVE COMPARATOR
Biological: Remicade

Interventions

PF-06438179BIOLOGICAL

Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1

Also known as: Infliximab-Pfizer
A = PF-06438179
RemicadeBIOLOGICAL

Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1

Also known as: Infliximab (European Union)
B = Infliximab-EU

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \>50kg (110 lbs).

You may not qualify if:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Previous exposure to a monoclonal antibody, or current use of other biologics.
  • History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
  • History of tuberculosis (TB) or a positive latent TB test at Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

  • Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.

    PMID: 29504427DERIVED

Related Links

MeSH Terms

Interventions

GP1111Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

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

April 29, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)