Skip to main content
OpenTrials
Completed

NCT Number: NCT01931189

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

NichiIko Investigational Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

NI-071

Biological

100mg/vial

Infliximab

Biological

100mg/vial

Other names: Remicade

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

  2. Safety : Incidence of Adverse Events

    Time frame: 8 weeks

  3. Safety : Incidence of Anti-Drug Antibodies(ADA)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Clinical Pharmacokinetics Study of NI-071

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2013
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.