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

NCT02985593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2023-08-30

No results posted yet for this study

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

DRUG

KHK4083

DRUG

Placebo

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-12-26
Completion
2017-12-26

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985593 on ClinicalTrials.gov