NCT05434156Active, not recruitingPhase 1/2
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
A Phase I, Randomised, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Intravenous Doses of ELE-101 in Healthy Adult Participants (Part 1) and Part 2, Open-Label Study to Evaluate a Range of Pharmacodynamic Effects of a Single Intravenous Dose of ELE-101 in Patients With Major Depressive Disorder.
Source: ClinicalTrials.gov · Last updated 19 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 15 Jun 2022
- Start date
- 27 Oct 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Eleusis Therapeutics
- Diseases
- Depression
- NCT number
- NCT05434156
- EudraCT number
- 2022-000150-29
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 84
- From 27 Oct 2022 to the primary completion date, Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Current, or history (within the last 6 months) of, alcohol or substance use disorder.
- 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).
- Part 1 Only: Ongoing current MDD, or history of MDD within the last year.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MAC Clinical Research Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| MAC Clinical Research Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.