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The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.
The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis.
Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject).
Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 in healthy subjects | Experimental | LEO 138559 (dose regiment 1) or LEO 138559 placebo |
|
| Cohort 2 in healthy subjects | Experimental | LEO 138559 (dose regiment 2) or LEO 138559 placebo |
|
| Cohort 3 in healthy subjects | Experimental | LEO 138559 (dose regiment 3) or LEO 138559 placebo |
|
| Cohort 4 in healthy subjects | Experimental | LEO 138559 (dose regiment 4) or LEO 138559 placebo |
|
| Cohort 5 in healthy subjects | Experimental | LEO 138559 (dose regiment 5) or LEO 138559 placebo |
|
| Cohort 6 in healthy subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 138559 | Drug | LEO 138559 is a compound in development at LEO Pharma A/S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of LEO 138559 - numbers of subjects with adverse events | Day 1 to Day 120 | |
| Safety of LEO 138559 - number of adverse events | Day 1 to Day 120 | |
| Tolerability of LEO 138559 - number of local site reactions | Day 1 to Day 120 |
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Inclusion Criteria:
For healthy subjects and subjects with atopic dermatitis:
For subjects with atopic dermatitis only:
Exclusion Criteria:
For healthy subjects and subjects with atopic dermatitis:
For subjects with atopic dermatitis only:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Leeds | United Kingdom | ||||
| Investigational site |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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LEO 138559 (dose regiment 6) or LEO 138559 placebo |
|
| Cohort 7 in healthy subjects | Experimental | LEO 138559 (dose regiment 7) or LEO 138559 placebo |
|
| Cohort 8 in subjects with atopic dermatitis | Experimental | LEO 138559 (dose regiment 8) or LEO 138559 placebo |
|
| Cohort 9 in subjects with atopic dermatitis | Experimental | LEO 138559 (dose regiment 9) or LEO 138559 placebo |
|
| LEO 138559 placebo | Drug | LEO 138559 placebo |
|
| Liverpool |
| United Kingdom |
| LEO Pharma investigational site | Manchester | United Kingdom |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |