PsoriasisPhase 1NCT01488201
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
A Phase 1 study testing KHK4827 in people with Psoriasis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- KHK4827
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Sep 2012
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health volunteers
- Able to provide written informed consent
- Healthy male between 20 to 45 years of age, inclusive at the time of screening
- Additional inclusion criteria apply
- Psoriasis subjects
- 20 to 70 years of age, inclusive at the time of screening
Show all 10Show fewer
- Active but clinically stable, plaque psoriasis
- Psoriasis involving ≥10% of the body surface area
- A minimum PASI score of ≥10 obtained during the screening period
- Additional inclusion criteria apply
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and Subjects With Moderate to Severe Psoriasis
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.
- Conditions
- Psoriasis
- Being tested
- Placebo, KHK4827
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
KHK4827Drug
| Study group | Role | What they receive |
|---|---|---|
| KHK4827 | Experimental | Not described Receives: Drug: KHK4827 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
- Adverse events
- Clinical laboratory test data
- Vital signs
Secondary outcomes (1)
Plasma KHK4827 concentrations and pharmacokinetic parameters
To assess PK parameters which include
- area under the plasma concentration versus time curve (AUC)
- peak plasma concentration (Cmax)
- t1/2
- CL
Measured: 16 time points up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Enrolment
- 48 participants (estimated)
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
- NCT01488201
- Sponsor's protocol ID
- 4827-001
- Status last verified
- Nov 2012
- First submitted
- 1 Dec 2011
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01488201
- Acronym / sponsor ID
- 4827-001
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Dec 2011 (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.
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK4827 | Experimental | Drug: KHK4827 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Health volunteers
- Able to provide written informed consent
- Healthy male between 20 to 45 years of age, inclusive at the time of screening
- Additional inclusion criteria apply
- Psoriasis subjects
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| KHK4827 | Drug | KHK4827 |
Primary outcome
Safety
* Adverse events * Clinical laboratory test data * Vital signs
1 secondary outcome
Plasma KHK4827 concentrations and pharmacokinetic parameters
Time frame: 16 time points up to 64 days
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 2 Nov 2012.
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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 KHK4827 in people with Psoriasis, 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 10 inclusion and 0 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 2 Nov 2012. 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?
Safety. 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 2 Nov 2012.