Pharmacokinetics Study of NI-071

Nichi-Iko Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: NI-071; Biological: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01931189

NI071A1

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

NI-071

Experimental group

Treatment:

Biological: NI-071

Infliximab

Active Comparator group

Treatment:

Biological: Infliximab