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

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

Healthy Men and Subjects With Ulcerative Colitis

Treatments

Drug: KHK4083

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02985593

4083-003

Details and patient eligibility

About

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.

Enrollment

155 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

"Part1:

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;

Part2:

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:
- 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)
- Severe chronic lung diseases requiring oxygen therapy
- Multiple sclerosis or other demyelinating diseases
- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma);
Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 2);
Suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data within 1 year prior to enrollment; suspected or confirmed toxic megacolon or history of toxic megacolon; history of any colonic resection, subtotal or total colectomy, ileostomy, or colostomy; or any previous surgery for ulcerative colitis or an anticipated requirement for surgery for ulcerative colitis;
Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);
Any planned surgical treatment during the study;
Clostridium difficile infection within 8 weeks prior to enrollment;
Any active infection, including Grade ≥2 localized diseases per Common Terminology Criteria for Adverse Events, version 4.0, Japan Clinical Oncology Group edition (CTCAE v4.0-JCOG), within 4 weeks prior to enrollment;
Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment;
Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;