NCT02985593

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

A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Men and Subjects With Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	KHK4083
DRUG	Placebo

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-26
• Completion: 2017-12-26
• First posted: 2016-12-07
• Last updated: 2023-08-30

Locations

1 site across 1 country: Japan