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

NCT02985593 | Completed Phase 1 DMC

• 1 other identifier: 4083-003
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Men and Subjects With Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• 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

• Time to reach Cmax (tmax) of KHK4083

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

• Area under the curve (AUC) 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

Study Arms (2)

KHK4083

EXPERIMENTAL

IV/SC administration

Drug: KHK4083

Placebo

PLACEBO COMPARATOR

IV/SC administration

Drug: Placebo

Interventions

KHK4083 DRUG

KHK4083

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current illness requiring treatment;
• Current respiratory, gastric, renal, or liver disease;
• Part2:
• 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;
• 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:
• 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
• Poorly controlled hypertension (systolic pressure \>150 mmHg or diastolic pressure \>90 mmHg at screening)

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Interventions

KHK4083

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 26, 2017
• Study Completion: December 26, 2017
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

JP (1)