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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT02985593
• Date of registration: 28/11/2016
• Prospective Registration: Yes
• Primary sponsor: Kyowa Kirin Co., Ltd.
• Public title: A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis
• Scientific 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
• Date of first enrolment: December 2016
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02985593
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion criteria

"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;



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Men and Subjects With Ulcerative Colitis

Intervention(s)

Drug: KHK4083

Drug: Placebo

Primary Outcome(s)

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 Outcome(s)

Anti-KHK4083 antibody production [Time Frame: art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration]

Time to reach Cmax (tmax) of KHK4083 [Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration]

Area under the curve (AUC) of KHK4083 [Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration]

Serum KHK4083 concentration [Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration]

Maximum concentration (Cmax) of KHK4083 [Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration]

Secondary ID(s)

4083-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors