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

Healthy Men and Subjects With Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985593
• Other study ID #: 4083-003
• Status: Completed
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: December 26, 2017

Study information

• Verified date: August 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 26, 2017
• Est. primary completion date: December 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

"Part1:

Inclusion Criteria:

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;

Exclusion Criteria:

1. Current illness requiring treatment;

2. Current respiratory, gastric, renal, or liver disease;

Part2:

Inclusion Criteria:

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. 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

• 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);

3. 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);

4. 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;

5. Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);

6. Any planned surgical treatment during the study;

7. Clostridium difficile infection within 8 weeks prior to enrollment;

8. 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;

9. Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment;

10. Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Healthy Men and Subjects With Ulcerative Colitis
• Ulcer

Intervention

Drug:
• KHK4083

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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