Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LEO 153339 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Cohort A1 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A2 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A3 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A4 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A5 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A6 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort A7 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| Cohort B1 LEO 153339 | EXPERIMENTAL | Single ascending dose (Part 1) |
| All SAD cohorts placebo | PLACEBO_COMPARATOR | Single ascending dose (Part 1), all participants receiving placebo in Cohorts A1-A7 and B1 |
| Cohort C1 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| Cohort C2 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| Cohort C3 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| Cohort C4 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| Cohort C5 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| Cohort C6 LEO 153339 | EXPERIMENTAL | Multiple ascending doses (Part 2) |
| All MAD cohorts placebo | PLACEBO_COMPARATOR | Multiple ascending doses (Part 2, all participants receiving placebo in Cohorts C1-C6) |
| Name | Type | Description |
|---|---|---|
| LEO 153339 | DRUG | LEO 153339 |
| Placebo | DRUG | Placebo |
Main Inclusion Criteria: * Healthy adult males and females. * Age between 18 and 65 years (both inclusive) at screening. * A body mass index (BMI) between 18.0 and 32.0 kg/m² (both inclusive). * In good health at screening and/or check-in (Day -2 and Day -1) as judged by the investigator based on m...
LEO 153339 is an investigational small molecule being studied in healthy adults. It is in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability. The drug is not approved and remains in early-stage clinical testing.
LEO 153339 is being developed by Icon Plc, a company listed on the NASDAQ under the ticker ICLR. The drug is currently in Phase 1 clinical development.
LEO 153339 is in Phase 1 clinical development. A Phase 1 trial in healthy adults has been completed, and the drug remains investigational. It has not been approved for any use.
LEO 153339 has one completed clinical trial, NCT04883333, titled "A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults." This Phase 1 study enrolled 108 participants in the Netherlands and was randomized, double-blind, and placebo-controlled.
LEO 153339 is the name used for this investigational drug in clinical development. No alternative names have been reported for this compound.