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ELE-101 · 1 trial · 3 indications
* 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,...
ELE-101 is an investigational small molecule being developed by AtaiBeckley Inc. for psychiatric use. It is currently in Phase 1 clinical development, studied in healthy volunteers as well as in patients with depression. The drug is being evaluated for safety and tolerability in an ongoing clinical trial.
ELE-101 is being studied for use in psychiatry, specifically in the treatment of major depressive disorder and depression. It is currently in Phase 1 clinical trials, where it is being tested in healthy volunteers and in patients with depression to assess its safety and tolerability.
ELE-101 is being developed by AtaiBeckley Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants and in patients with depression.
ELE-101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is assessing its safety and tolerability in healthy volunteers and in patients with depression.
ELE-101 is being studied in a Phase 1 clinical trial with the identifier NCT05434156. This trial is titled 'ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression' and is enrolling 84 participants in the United Kingdom. The study is active but not currently recruiting.
ELE-101 is a distinct investigational drug candidate. It is being developed under this name by AtaiBeckley Inc. and is currently in Phase 1 clinical trials for psychiatric indications, including depression.