Healthy
Conditions
Brief summary
The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers
Interventions
BIOLOGICALNI-071
100mg/vial
BIOLOGICALInfliximab
100mg/vial
Sponsors
Nichi-Iko Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed