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

Kyowa Kirin Co., Ltd.0 sites155 target enrollmentDecember 2016

ConditionsHealthy Men and Subjects With Ulcerative Colitis

InterventionsKHK4083 Placebo

DrugsKHK4083 Placebo

Overview

Phase: Phase 1
Intervention: KHK4083
Conditions: Healthy Men and Subjects With Ulcerative Colitis
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 155
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

December 26, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary written informed consent to participate in the study;
•Japanese or White men ≥20 and \<45 years at the time of informed consent;

Exclusion Criteria

•Current illness requiring treatment;
•Current respiratory, gastric, renal, or liver disease;
•Inclusion Criteria:
•Voluntary written informed consent to participate in the study;
•Men or women ≥20 years of age at the time of informed consent;
•Ulcerative colitis diagnosed ≥6 months prior to informed consent;
•Moderate or more severe ulcerative colitis;
•Exclusion Criteria:
•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;
•Any of the following clinically significant concurrent illnesses:

Arms & Interventions

KHK4083

IV/SC administration

Intervention: KHK4083

Placebo

IV/SC administration

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature

Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration

Secondary Outcomes

Area under the curve (AUC) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
Time to reach Cmax (tmax) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
Serum KHK4083 concentration(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
Maximum concentration (Cmax) of KHK4083(Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)
Anti-KHK4083 antibody production(art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration)