Active not recruitingPHASE1, PHASE2INTERVENTIONAL

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

This study is investigating a new medication, ELE-101, for people experiencing depression. It's split into two main parts. The first part focuses on healthy volunteers, carefully checking the drug's safety, how well their bodies handle it, and any initial effects. This helps researchers understand the basic reactions to ELE-101. The second part then looks at a small group of people who have depression, giving them ELE-101 to see how it affects them. The main goals are to make sure the drug is safe and well-tolerated, and to learn more about how it works in the body, with the hope of finding new ways to help those with depression.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Eleusis Therapeutics

Enrolment target

Start

27 Oct 2022

Estimated completion

01 Mar 2026

Healthy Volunteers Major Depressive Disorder Depression

What is this study about?

This research study is all about a new investigational drug called ELE-101, which doctors are exploring as a potential treatment for depression. When new medicines are developed, they have to go through several careful stages to make sure they are safe and effective before they can be widely used.

This particular study has two main parts. In the first part, healthy adult volunteers are taking part. They will receive ELE-101, or a placebo (a dummy drug with no active ingredients), to help researchers understand how their bodies react to the drug. This involves checking for any side effects, seeing how the drug is absorbed and leaves the body, and understanding its initial impacts. This step is crucial for gathering important safety information.

The second part of the study focuses on people who have been diagnosed with depression. These participants will receive ELE-101. The main aim here is to see how the drug affects them, looking at how it works in the body and if it has any helpful effects on their mood. By doing this, researchers hope to learn more about ELE-101 and whether it could be a useful new option for people living with depression.

Key takeaways

This study is testing a new drug, ELE-101, for depression.
It first checks safety in healthy adults and then explores effects in people with depression.
Participation involves receiving the drug via a drip and attending assessments.
You might receive ELE-101 or a placebo, depending on the study part.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. Your body mass index (BMI) should be between 18 and 35. You must be happy to sign a consent form, follow all study instructions, and be able to clearly tell the doctors how you are feeling.

For the second part of the study, you must have a diagnosis of depression and not currently be taking any other antidepressant medications.

There are also some reasons why you might not be able to join. For example, if you have a history of alcohol or drug problems in the last six months, or if you've recently taken medicines for mental health or brain conditions. Certain other mental health conditions, either for yourself or close family members, would also mean you couldn't take part. If there's a significant risk of you harming yourself, or if the doctors feel the study isn't right for you for other safety reasons, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have a current diagnosis of depression (for Part 2 only)?
Are you currently not taking antidepressant medication (for Part 2 only)?
Have you had alcohol or drug problems in the last 6 months?
Do you have other significant mental health conditions like schizophrenia or bipolar disorder?
Are you able to attend appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be participating in a clinical trial to test ELE-101. Depending on which part of the study you are in, you will either receive ELE-101 or a placebo (a dummy drug). In both cases, the study drug will be given into your vein through a drip. You will have regular check-ups, which include blood tests, physical examinations, and answering questions about how you are feeling and any effects you notice. The study team will explain exactly what is involved during your appointments. The total duration of your involvement will be discussed in detail by the study team, but it will include initial screening, the day(s) you receive the drug, and follow-up assessments.

Potential risks and benefits

Participating in research studies like this helps advance medical knowledge and could potentially lead to new treatments for depression. You might also receive careful medical monitoring. However, there are potential risks, as ELE-101 is an investigational drug, meaning its full effects are not yet known. You might experience side effects, which could be mild or, in rare cases, more serious. Receiving an infusion can also come with its own risks, like bruising or discomfort at the injection site. It's very important to remember that joining this study is entirely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

MAC Clinical Research
Verified postcode
Liverpool, United Kingdom
MAC Clinical Research
Verified postcode
Manchester, United Kingdom

Common questions

What is ELE-101?

ELE-101 is a new medication being tested to see if it can help people with depression. It's not yet available as a regular treatment.

What is a placebo?

A placebo is a substance that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects.

Will I know if I'm getting the real drug or a placebo?

In the first part of the study, neither you nor the study team will know if you're getting ELE-101 or the placebo. This is called 'double-blind' and helps keep the results unbiased.

How will the drug be given to me?

The study drug, ELE-101, will be given to you through a drip into a vein, which is called an intravenous (IV) infusion.

Can I continue my regular depression medication if I join?

For the second part of the study, participants with depression should not be taking antidepressant medication. This will be discussed fully with the study team.