Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04933565 | First in Human Study of ORG-129 in Healthy Volunteers | PHASE1 | COMPLETED | 81 | — | — | Jun 1, 2021 | Jan 9, 2023 | Jan 17, 2023 | 1 | Spain |
by assessing the number, severity and type of treatment emergent adverse events
by assessing the number, severity and type of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| ORG-129 | EXPERIMENTAL | Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort |
| Placebo | PLACEBO_COMPARATOR | Single ascending dose (up to 4 cohorts), Multiple ascending dose (up to 4 cohorts), Food interaction cohort, Multiple dose PK/PD cohort |
| Name | Type | Description |
|---|---|---|
| ORG-129 | DRUG | ORG-129 oral capsules |
| Placebo | DRUG | Placebo oral capsules |
Inclusion Criteria: To be included in the Single Dose Study, subjects should meet all the following criteria at the screening visit: 1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment. 2. Body weight within normal range (Quetelet's index between 19 and 27) expressed ...