LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects
![]() |
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: NCT00833872 |
Recruitment Status
:
Completed
First Posted
: February 2, 2009
Last Update Posted
: March 3, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis Vulgaris | Drug: LEO 22811 Drug: placebo solution | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
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 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | November 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: LEO 22811 solution |
Drug: LEO 22811
First-in-man
|
Placebo Comparator: placebo solution | Drug: placebo solution |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: (in summary)
- 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
Exclusion Criteria: (in summary)
- 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
- 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

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): NCT00833872
United Kingdom | |
Covance Clinical Research Unit Ltd | |
Leeds, United Kingdom, LS2 9LH |
Principal Investigator: | Douglas Lee | Covance |
Responsible Party: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00833872 History of Changes |
Other Study ID Numbers: |
LEO 22811-S21 |
First Posted: | February 2, 2009 Key Record Dates |
Last Update Posted: | March 3, 2016 |
Last Verified: | March 2016 |
Additional relevant MeSH terms:
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Pharmaceutical Solutions |