NCT01931189

Brief Summary

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

August 26, 2013

Last Update Submit

June 27, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (3)

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

    8 weeks

  • Safety : Incidence of Adverse Events

    8 weeks

  • Safety : Incidence of Anti-Drug Antibodies(ADA)

    8 weeks

Study Arms (2)

NI-071

EXPERIMENTAL
Biological: NI-071

Infliximab

ACTIVE COMPARATOR
Biological: Infliximab

Interventions

NI-071BIOLOGICAL

100mg/vial

NI-071
InfliximabBIOLOGICAL

100mg/vial

Also known as: Remicade
Infliximab

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
  • Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

You may not qualify if:

  • Subjects with a following past History or concomitant diseases
  • Chronic or recurrent infectious disease
  • Demyelinating disease
  • Congestive heart failure
  • lymphoproliferative disorder or myelodysplastic syndrome
  • Malignancy
  • Interstitial lung disease
  • Subjects with active or latent tuberculosis or history of tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NichiIko Investigational Site

Tokyo, Japan

Location

MeSH Terms

Interventions

Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

JP(1)