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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005748-51 | EudraCT Number | ||
| U1111-1283-2001 | Other Identifier | World Health Organization (WHO) |
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo.
The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body.
The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Cohort A2 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Cohort A3 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Cohort A4 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Cohort A5 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Cohort A6 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 153339 | Drug | LEO 153339 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events per subject. | An adverse event will be considered treatment emergent if started after the first dose of investigational medicinal product (IMP) or if started before the first dose of IMP and worsened in severity after first dose of IMP. | 4 days per subject (Part 1); 10 days per subject (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of LEO 153339 and LEO 159074 obtained from 0 to 72 hours post-dose in subjects from the single ascending-dose (SAD) cohorts. | The pharmacokinetics of LEO 153339 and LEO 159074 will be evaluated in plasma. | 72 hours per subject |
| Plasma concentration of LEO 153339 and LEO 159074 obtained from Day 1 to Day 7 post-dose with PK profiles on Day 1, Day 5, and Day 7 in subjects from the multiple ascending-dose (MAD) cohorts. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Groningen | NZ | 9728 | Netherlands |
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| Cohort A7 LEO 153339 |
| Experimental |
Single ascending dose (Part 1) |
|
| Cohort B1 LEO 153339 | Experimental | Single ascending dose (Part 1) |
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| All SAD cohorts placebo | Placebo Comparator | Single ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1 |
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| Cohort C1 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| Cohort C2 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| Cohort C3 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| Cohort C4 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| Cohort C5 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| Cohort C6 LEO 153339 | Experimental | Multiple ascending doses (Part 2) |
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| All MAD cohorts placebo | Placebo Comparator | Multiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6) |
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| Placebo | Drug | Placebo |
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The pharmacokinetics (PK) of LEO 153339 and LEO 159074 will be evaluated in plasma. |
| 10 days per subject |