A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KHK4083 IV/SC administration |
Drug: KHK4083
|
| Placebo Comparator: Placebo IV/SC administration |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tokyo | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4083-003