Psoriasis VulgarisPhase 1NCT00833872
LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects
A Phase 1 study testing LEO 22811 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 22811
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Nov 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be Caucasian males or females of non-child bearing potential between 18 and 65 years of age
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Women of childbearing potential
- Subjects with an infectious illness within 3 days prior to dosing
- Subjects with a history of tuberculosis
- Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) within 14 days of the first dose administration
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration
- In Part 2, subjects who have received or been exposed to Cloroquine products, endoxan, or any immunomodulating agent (e.g. azathioprin) within one month prior to the start of dosing
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- Subjects who are participating in a clinical study
- Subjects with a significant history of drug allergy or with a known or suspected hypersensitivity to any of the components of LEO 22811 as determined by the Investigator
- Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator
- Subjects who have a supine blood pressure and supine pulse rate at screening higher than 150/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/40 mmHg and 50 bpm, respectively
- Subjects who have PR interval >= 200 ms, QTc(b) interval >450 ms (males) or > 470 ms (females), or who exhibit U waves of atrio-ventricular blocks at screening, based on 12-lead ECGs
- Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome)
- Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
- Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LEO 22811 - A Phase I, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811 will be administered to healthy male subjects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 22811, placebo solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 22811Drug
First-in-man
placebo solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 22811 solution | Experimental | Not described Receives: Drug: LEO 22811 |
| placebo solution | Placebo comparator | Not described Receives: Drug: placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of ascending single and multiple oral doses of LEO 22811 in healthy male subjects.
Measured: 4 days
To determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Lee, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833872
- Sponsor's protocol ID
- LEO 22811-S21
- Status last verified
- Mar 2016
- First submitted
- 30 Jan 2009
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 22811 - A Phase I, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00833872
- Acronym / sponsor ID
- LEO 22811-S21
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Feb 2009 (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 purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811 will be administered to healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 22811 solution | Experimental | Drug: LEO 22811 |
| placebo solution | Placebo comparator | Drug: placebo solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will be Caucasian males or females of non-child bearing potential between 18 and 65 years of age
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (16 listed)
- Women of childbearing potential
- Subjects with an infectious illness within 3 days prior to dosing
- Subjects with a history of tuberculosis
- Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) within 14 days of the first dose administration
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration
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 |
|---|---|---|
| LEO 22811First-in-man | Drug | LEO 22811 solution |
| placebo solution | Drug | placebo solution |
Primary outcome
To determine the safety and tolerability of ascending single and multiple oral doses of LEO 22811 in healthy male subjects.
Time frame: 4 days
To determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects.
Time frame: 4 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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Douglas Lee principal investigator
Covance
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 LEO 22811 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
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 2 inclusion and 16 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 24 Feb 2025. 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 United Kingdom. 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?
To determine the safety and tolerability of ascending single and multiple oral doses of LEO 22811 in healthy male subjects. (time frame: 4 days). The study lists 2 primary outcomes in all. 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 24 Feb 2025.