* 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.
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
Brief Summary
A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).
Intervention / Treatment
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ELE-101 (DRUG)ELE-101 solution for intravenous infusion
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ELE-101 Placebo (DRUG)ELE-101 placebo matching solution for intravenous infusion
Condition or Disease
- Healthy Volunteers
- Major Depressive Disorder
- Depression
Phase
Study Design
| Study type: | INTERVENTIONAL |
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| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 84 (ESTIMATED) |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingOpen label in Part 2 TRIPLE:
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Clinical Trial Dates
| Start date: | Oct 27, 2022 | ACTUAL |
|---|---|---|
| Primary Completion: | Dec 01, 2023 | ESTIMATED |
| Completion Date: | Dec 01, 2023 | ESTIMATED |
| Study First Posted: | Jun 27, 2022 | ACTUAL |
| Last Updated: | Aug 14, 2023 |
Sponsors / Collaborators
This is a 2-part study. Part 1 is a phase I, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective drug intensity (SDI) of single ascending intravenous (IV) doses of ELE-101 in healthy male and female adult participants. Part 2 is a Phase IIa, open-label study to evaluate a range of pharmacodynamic effects of a single intravenous dose of ELE-101 in patients with depression.
Healthy participants will receive either ELE-101 or placebo as an IV infusion in Part 1 and patients with MDD will receive ELE-101 as an IV infusion in Part 2.
Healthy participants will receive either ELE-101 or placebo as an IV infusion in Part 1 and patients with MDD will receive ELE-101 as an IV infusion in Part 2.
Participant Groups
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A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
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A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
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A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
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A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
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A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo)
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A single TBD minute intravenous infusion of TBD mg ELE-101
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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, undergo the examinations and testing set forth in the study Protocol and clearly and reliably communicate their subjective symptoms to the Investigator.
* Part 2 Only: Patient has a diagnosis of MDD and is not on antidepressant medication.
Exclusion Criteria:
* Current, or history (within the last 6 months) of, alcohol or substance use disorder.
* Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS within 30 days or 5 half-lives (whichever is longer) prior to Screening.
* Current or clinically relevant history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder or panic disorder.
* In first-degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
* History of a diagnosis of Hallucinogen Persistent Perceptual Disorder (HPPD).
* Significant suicide risk.
* Other personal circumstances and behavior that is incompatible with establishment of rapport or safe exposure to psilocin, as judged by the Investigator.
* Part 1 Only: Ongoing current MDD, or history of MDD within the last year.
* 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, undergo the examinations and testing set forth in the study Protocol and clearly and reliably communicate their subjective symptoms to the Investigator.
* Part 2 Only: Patient has a diagnosis of MDD and is not on antidepressant medication.
Exclusion Criteria:
* Current, or history (within the last 6 months) of, alcohol or substance use disorder.
* Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS within 30 days or 5 half-lives (whichever is longer) prior to Screening.
* Current or clinically relevant history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder or panic disorder.
* In first-degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
* History of a diagnosis of Hallucinogen Persistent Perceptual Disorder (HPPD).
* Significant suicide risk.
* Other personal circumstances and behavior that is incompatible with establishment of rapport or safe exposure to psilocin, as judged by the Investigator.
* Part 1 Only: Ongoing current MDD, or history of MDD within the last year.
This clinical trial is recruiting
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Primary Outcomes
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- The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience
Secondary Outcomes
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
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The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.
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The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10.
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The MADRS is a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.
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* 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.
More Details
| NCT Number: | NCT05434156 |
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| Other IDs: | ET1001-ELE-101 |
| Study URL: | https://clinicaltrials.gov/study/NCT05434156 |
Last updated: Sep 29, 2023