Pharmacokinetics Study of NI-071

June 27, 2014 updated by: Nichi-Iko Pharmaceutical Co., Ltd.

A Clinical Pharmacokinetics Study of NI-071

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • NichiIko Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Subjects with active or latent tuberculosis or history of tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NI-071
Biological: NI-071
100mg/vial
Active Comparator: Infliximab
Biological: Infliximab
100mg/vial
Other Names:
  • Remicade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Time Frame: 8 weeks
8 weeks
Safety : Incidence of Adverse Events
Time Frame: 8 weeks
8 weeks
Safety : Incidence of Anti-Drug Antibodies(ADA)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI071A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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