Pharmacokinetics Study of NI-071
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: InfliximabBiological: NI-071
- Registration Number
- NCT01931189
- Lead Sponsor
- Nichi-Iko Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infliximab Infliximab - NI-071 NI-071 -
- Primary Outcome Measures
Name Time Method PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) 8 weeks
- Secondary Outcome Measures
Name Time Method Safety : Incidence of Adverse Events 8 weeks Safety : Incidence of Anti-Drug Antibodies(ADA) 8 weeks PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) 8 weeks
Trial Locations
- Locations (1)
NichiIko Investigational Site
🇯🇵Tokyo, Japan