Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Safety, tolerability and effect of DLX-001 in healthy volunteers

This study is researching a new medicine called DLX-001. We want to find out if it is safe and how well healthy people tolerate it. This is a very early stage of research, called Phase 1, which means it's the first time this medicine is being given to people. The main goal is to understand how the body deals with the medicine and if there are any side effects. This kind of study doesn't aim to treat depression directly at this stage, but it's an important step to see if DLX-001 could potentially be developed into a treatment for unipolar depression in the future. Participants need to be at least 18 years old and can be male or female.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Delix Therapeutics Inc.

Enrolment target

106

Start

12 Apr 2023

Unipolar depression (UD)

What is this study about?

This research is looking into a new potential medicine called DLX-001. Think of it like taking the very first steps on a long journey to find new treatments. At this stage, we are mainly focused on safety. We want to understand what happens when healthy people take this new medicine for the first time. This includes checking for any unexpected effects and seeing how the body processes the medication.

The study is called a 'Phase 1' trial. This means it's the very first time the medicine is being tested in humans. It's not about treating an illness yet, but about making sure it's safe enough to continue testing in future, larger studies. Future studies might then explore if it can help people with unipolar depression.

While this specific study is for healthy volunteers, the aim of developing DLX-001 is to potentially help people living with unipolar depression. Unipolar depression is a common mental health condition where people experience persistent low mood, loss of pleasure, and other symptoms. Finding new, safe and effective treatments is really important, and studies like this are the starting point for that process.

Key takeaways

Tests a new medicine (DLX-001) for the first time in humans.
Mainly designed to check if the medicine is safe and how the body reacts to it.
For healthy adults aged 18 and over, both men and women.
An early stage research step towards potential future depression treatments.
Participation involves taking the medicine and regular health check-ups.
You can stop participating at any time.

Who may be eligible?

To join this study, we are looking for healthy adults. This means you should generally be in good health and not have any significant medical conditions that might be affected by the study medicine.

Participants must be at least 18 years old, and there is no upper age limit, meaning older adults can also take part. Both men and women are welcome to apply to be part of this research, as we want to understand how the medicine affects different people.

Because this is a very early study and we want to focus on how the new medicine works in a healthy body, you would not be able to participate if you currently have unipolar depression or other significant health issues. The research team will do some checks to make sure the study is suitable for you.

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 18 years old or older?
Are you generally in good health?
Do you not have unipolar depression or other serious medical conditions?
Are you able to attend appointments at a study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, DLX-001. This is a "first-in-human" study, so the doctors will be very careful in monitoring you. You would likely have several visits to the study clinic for check-ups, blood tests, and other assessments to see how you are responding to the medicine and if there are any side effects. These visits might be quite frequent at the beginning.

You'll be asked to follow specific instructions about taking the medicine and probably about your diet and other activities. The study team will keep a close eye on your health throughout. The total time you'd be involved in the study, including follow-up appointments after you stop taking the medicine, would be fully explained by the research team.

Potential risks and benefits

Potential benefits of taking part could include knowing you're helping advance medical science, which might lead to new treatments for depression in the future. You will also receive careful health monitoring throughout the study. However, because this is a new medicine, there might be unknown risks or side effects that we don't yet fully understand. These could range from mild discomfort to more serious reactions. You will be closely watched by the medical team. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is DLX-001?

DLX-001 is a new medicine being tested for the first time in people. We want to see if it's safe and how it works in the body.

Am I taking this medicine to treat depression?

No, this study is for healthy volunteers and is not aiming to treat depression. It's about checking the medicine's safety in people.

Who can join this study?

Healthy adults aged 18 or over, both men and women, can potentially join.

What is a Phase 1 study?

It's the very first step in testing a new medicine in people. The main goal is to check for safety and how the body handles it.

Will I get paid for taking part?

Sometimes studies offer payment for your time and travel. This would be clearly explained by the research team if applicable.