Pharmacokinetics Study of NI-071

Healthy Clinical Trial

Official title:

A Clinical Pharmacokinetics Study of NI-071

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931189
• Other study ID #: NI071A1
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2013
• Last updated: June 27, 2014
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Nichi-Iko Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• NI-071
100mg/vial
• Infliximab
100mg/vial

Locations

Country	Name	City	State
Japan	NichiIko Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nichi-Iko Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)		8 weeks	No
Secondary	PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)		8 weeks	No
Secondary	Safety : Incidence of Adverse Events		8 weeks	Yes
Secondary	Safety : Incidence of Anti-Drug Antibodies(ADA)		8 weeks	Yes