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Trial record 2 of 4 for:    KHK4083

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985593
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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
Healthy Men and Subjects With Ulcerative Colitis Drug: KHK4083 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 26, 2017
Actual Study Completion Date : December 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KHK4083
IV/SC administration
Drug: KHK4083
Placebo Comparator: Placebo
IV/SC administration
Drug: Placebo



Primary Outcome Measures :
  1. 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 Measures :
  1. Serum KHK4083 concentration [ Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration ]
  2. Maximum concentration (Cmax) of KHK4083 [ Time Frame: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration ]
  3. 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 ]
  4. 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 ]
  5. Anti-KHK4083 antibody production [ Time Frame: art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985593


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02985593    
Other Study ID Numbers: 4083-003
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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KHK4083
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Dermatologic Agents