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

Depression Clinical Trial

Official title: 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 A Phase IIa, Open-Label Study to Evaluate a Range of Pharmacodynamic Effects of a Single Intravenous Dose of ELE-101 in Patients With Major Depressive Disorder (Part 2).

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Healthy Volunteers
• Major Depressive Disorder

• NCT number: NCT05434156
• Study type: Interventional
• Source: Eleusis Therapeutics
• Contact: Beckley Psytech Ltd
• Phone: +44 (0)1865 987633
• Email: Medinfo@beckleypsytech.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 27, 2022
• Completion date: September 2024