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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05434156 | ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression | PHASE1 | ACTIVE NOT_RECRUITING | 84 | — | — | Oct 27, 2022 | Mar 1, 2026 | Feb 19, 2025 | 2 | United Kingdom |
* Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments, injection site reactions and physical examination findings. * Suicidal ideation and behavior will be evaluated using the Columbia-Suicide Severity Rating Scale (C-SSRS). * Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured. * Tolerability will be measured using the SDI questionnaires to rate the intensity of the psychedelic experience alongside recordings of anticipated adverse effects such as nausea and headache.
\- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Part 1) | EXPERIMENTAL | A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
| Cohort 2 (Part 1) | EXPERIMENTAL | A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
| Cohort 3 (Part 1) | EXPERIMENTAL | A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
| Cohort 4 (Part 1) | EXPERIMENTAL | A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
| Cohort 5 (Part 1) | EXPERIMENTAL | A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
| Cohort 6 (Part 2) | EXPERIMENTAL | A single TBD minute intravenous infusion of TBD mg ELE-101 |
| Name | Type | Description |
|---|---|---|
| ELE-101 | DRUG | ELE-101 solution for intravenous infusion |
| ELE-101 Placebo | DRUG | ELE-101 placebo matching solution for intravenous infusion |
Inclusion Criteria: * Healthy male or female participants aged 18 to 65 years, inclusive. * Participants have a body mass index (BMI) of 18 to 35 kg/m2, inclusive. * Participants are able and willing to give written informed consent, adhere to the compliance terms during participation in the study,...