LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects
NCT00833872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2025-02-24
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. 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
Interventions
- DRUG
-
placebo solution
- DRUG
-
LEO 22811
First-in-man
Sponsors & Collaborators
-
LEO Pharma
lead INDUSTRY
Principal Investigators
-
Douglas Lee · Covance
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-11-30
Countries
- United Kingdom
Study Locations
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