drugset / Trial / NCT02985593

A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis

NCT02985593

Phase 1 Completed 155 enrolled Kyowa Kirin, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

The objectives of this study are to evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an open-label study.

Timeline

Start
2016-12
Primary completion
2017-12-26
Completion
2017-12-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Rocatinlimab Monoclonal antibody Intravenous

Indications

No indication recorded.