Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of quantitative sensory testing (QST) using subcutaneous administration of single escalating doses of halneuron® (tetrodotoxin (TTX)) for injection in healthy volunteers

Researchers are conducting a study to learn more about a new medicine called HALNEURON. This medicine contains a substance called tetrodotoxin (TTX) and is given by injection. The study is for healthy volunteers, meaning people who don't have existing health conditions. The main goal is to see how different single doses of HALNEURON affect how people sense things like touch, temperature, or pressure. This is measured using special tests called Quantitative Sensory Testing (QST). The researchers want to understand if this medicine changes these sensations, which could help in developing new ways to treat pain in the future. They will also check for any side effects and how the medicine affects other senses like smell, and the body's breathing response to low oxygen.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leiden University Medical Center

Enrolment target

Start

21 Jul 2023

pain

What is this study about?

Imagine you're trying a new ingredient in cooking – you want to know how much to use and what effect it has. That's a bit like what researchers are doing with a new medicine called HALNEURON. This study is in an early stage, called 'Phase II', which means they're exploring how it works and if it has any potential benefits.

The main idea behind HALNEURON is that it contains a substance called tetrodotoxin (TTX). This substance is known to affect how our nerves send messages, and this could be useful for managing pain. In this study, healthy volunteers will receive single, small doses of HALNEURON. The main aim is to see if and how these doses change how sensitive people are to different feelings like touch, hot, or cold. They use special, gentle tests called Quantitative Sensory Testing (QST) to measure this precisely.

By carefully observing these changes and any side effects, the researchers hope to learn more about how HALNEURON works in the body. This information is crucial for deciding if this medicine could be a safe and effective way to help people who experience pain in the future. It's a stepping stone in the journey of developing new treatments.

Key takeaways

This is an early-stage study testing a new medicine called HALNEURON.
It's for healthy volunteers aged 18 and over.
The study aims to see how various doses affect your senses, particularly touch and temperature.
This research could help develop new pain treatments in the future.
You will receive an injection and undergo gentle sensory tests.
Your safety will be closely monitored throughout the study.

Who may be eligible?

This study is looking for healthy volunteers. This means people who generally feel well and don't have any major ongoing health problems.

You need to be 18 years old or older to take part. There's no upper age limit, but you would still need to meet other health requirements.

Both men and women are welcome to participate in this study. The most important thing is that you are healthy, as confirmed by the study doctors after a check-up.

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?
Do you consider yourself generally healthy?
Are you able to attend clinic visits as required?
Are you able to understand and be willing to follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the clinic for several appointments. On one or more of these visits, you'll receive a single injection of HALNEURON at a specific dose. Before and after the injection, you'll have several tests to measure your senses, like how you feel touch or temperature. These are called Quantitative Sensory Tests (QST) and are gentle and non-invasive.

The research team will also check your breathing, your sense of smell, and ask you about any side effects you might experience. They will monitor you closely after the injection to ensure your safety. The total time you'll spend in the study, including all visits and follow-ups, will be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in a study like this helps advance medical science and could lead to new treatments for pain in the future, which is a potential benefit to others. However, as with any new medicine, there might be risks, such as side effects from the injection or the medicine itself. These will be carefully monitored by the study team, and you will be fully informed of all known risks before you decide to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 HALNEURON?

HALNEURON is a new medicine being tested. It contains a substance called tetrodotoxin (TTX) and is given by injection.

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how the medicine works in the body without other health conditions making it complicated.

What are Quantitative Sensory Tests (QST)?

QST are gentle tests that measure how well you feel different sensations, like touch, warmth, or coolness, using special tools.

Will I receive pain relief in this study?

This study is not designed to treat pain. It's an early-stage study to understand how the medicine affects senses in healthy people, which could potentially help with pain research later on.

What happens if I feel unwell during the study?

The study team will monitor you closely, and you can report any symptoms or concerns immediately. Your safety is a top priority.