Healthy Men and Subjects With Ulcerative ColitisPhase 1NCT02985593
A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis
A Phase 1 study testing KHK4083 in people with Healthy Men and Subjects With Ulcerative Colitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Subjects With Ulcerative Colitis
- What is being tested?
- KHK4083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2016to 26 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent to participate in the study;
- Japanese or White men ≥20 and <45 years at the time of informed consent;
- 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;
Who cannot join
- Current illness requiring treatment;
- Current respiratory, gastric, renal, or liver disease;
- Part2:
- 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
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- KHK4083, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4083Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KHK4083 | Experimental | IV/SC administration Receives: Drug: KHK4083 |
| Placebo | Placebo comparator | IV/SC administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Measured: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Secondary outcomes (5)
Serum KHK4083 concentration
Measured: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Maximum concentration (Cmax) of KHK4083
Measured: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Time to reach Cmax (tmax) of KHK4083
Measured: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Area under the curve (AUC) of KHK4083
Measured: Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Anti-KHK4083 antibody production
Measured: art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion26 Dec 2017
- Study completion26 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and Subjects With Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985593
- Sponsor's protocol ID
- 4083-003
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2016
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02985593
- Acronym / sponsor ID
- 4083-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK4083 | Experimental | Drug: KHK4083IV/SC administration |
| Placebo | Placebo comparator | Drug: PlaceboIV/SC administration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent to participate in the study;
- Japanese or White men ≥20 and <45 years at the time of informed consent;
- 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;
Key exclusion criteria (22 listed)
- Current illness requiring treatment;
- Current respiratory, gastric, renal, or liver disease;
- 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:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHK4083 | Drug | KHK4083 |
| Placebo | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
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
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
Anti-KHK4083 antibody production
Time frame: art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KHK4083 in people with Healthy Men and Subjects With Ulcerative Colitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.