ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

A study in healthy adult participants to assess the safety and tolerability of a drug called ELE-101 (psilocybin) and see how the body absorbs and removes the drug and how it affects the body.

Original title: ELE-101 Safety & Tolerability Study in Healthy Participants

Status Not yet recruiting
Results Published No
Start date 20 July 2022
End date 30 November 2022
Design Blinded
Type Interventional
Generation Second
Participants 60
Sex All
Age 18- 65
Therapy No

Trial Details

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.

NCT Number NCT05434156

Sponsors & Collaborators

Eleusis
Eleusis is a clinical-stage life sciences company that studies and develops psychedelic drugs for therapeutic use. Since 2013 the company has been researching psychedelics and is now developing ELE-Psilo (psilocybin) for depression that is in Phase I.

Data attribution

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