Loading clinical trials...

A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02985593•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•"Part1:
•1. Voluntary written informed consent to participate in the study;
•2. Japanese or White men ≥20 and \<45 years at the time of informed consent;
•1. Voluntary written informed consent to participate in the study;
•2. Men or women ≥20 years of age at the time of informed consent;
•3. Ulcerative colitis diagnosed ≥6 months prior to informed consent;
•4. Moderate or more severe ulcerative colitis;

Exclusion Criteria

•1. Current illness requiring treatment;
•2. Current respiratory, gastric, renal, or liver disease;
•Part2:
•1. Definitive diagnosis of bacillary dysentery, amebic colitis, Salmonella enteritis, Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis, Crohn's disease, radiation colitis, drug-induced colitis, angiolymphoid hyperplasia, ischemic colitis, or intestinal Behcet's disease;
•2. Any of the following clinically significant concurrent illnesses:
•* Type 1 diabetes
•* Poorly controlled type 2 diabetes (HbA1c \>8.5%)
•* Congestive heart failure (class II to IV of the New York Heart Association classification)
•* Myocardial infarction within 1 year
•* Unstable angina pectoris within 1 year
+12 more criteria

Locations (1)

Tokyo, Japan

Key Dates

Start Date

December 1, 2016

Primary Completion Date

December 26, 2017

Completion Date

December 26, 2017

Last Updated

August 30, 2023

Enrollment

155

ACTUAL participants

Conditions

Healthy Men and Subjects With Ulcerative Colitis

Interventions

KHK4083

DRUG

Placebo

DRUG