Pharmacokinetics Study of NI-071

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

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