ELE-101 Safety & Tolerability Study in Healthy Participants
Study Details
Study Description
Brief Summary
A study in healthy adult participants 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This 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.
Participants will receive either ELE-101 or placebo as an IV infusion.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
Drug: ELE-101
ELE-101 solution for intravenous infusion
Drug: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
|
| Experimental: Cohort 2 A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
Drug: ELE-101
ELE-101 solution for intravenous infusion
Drug: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
|
| Experimental: Cohort 3 A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
Drug: ELE-101
ELE-101 solution for intravenous infusion
Drug: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
|
| Experimental: Cohort 4 A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
Drug: ELE-101
ELE-101 solution for intravenous infusion
Drug: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
|
| Experimental: Cohort 5 A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
Drug: ELE-101
ELE-101 solution for intravenous infusion
Drug: ELE-101 Placebo
ELE-101 placebo matching solution for intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with at least one safety event [Baseline up to Day 8]
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.
Secondary Outcome Measures
- Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- AUClast: Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- AUC0-24: Area under the plasma concentration-time curve from Time 0 to 24 hours for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- VZss: volume of distribution at steady state for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- Cl: apparent total clearance from plasma for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites [pre-dose and at multiple time-points up to 24 hours post-dose]
PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study
- Dischargeability: Assessment of subject-discharge readiness [post-dose and 24 hours post-dose]
The dischargeability evaluation will be based on Investigator judgement after review of participant safety data.
- The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale [pre-dose and at multiple time-points up to 24 hours post-dose]
The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10.
Eligibility Criteria
Criteria
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.
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.
-
Ongoing current MDD, or history of MDD within the last year.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MAC Clinical Research | Liverpool | United Kingdom | L34 1BH | |
| 2 | MAC Clinical Research | Manchester | United Kingdom | M13 9NQ |
Sponsors and Collaborators
- Eleusis Therapeutics
Investigators
- Principal Investigator: Fabian Devlin, MD, MAC Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ET1001-ELE-101
- 2022-000150-29