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

A Phase 1, randomized, double blind, single center, placebo controlled, single escalating weight-adjusted dose, safety study of HI-6 dimethyl sulfonate (HI-6 DMS) administered by iv bolus and infusion in healthy volunteers

This study is an early research stage to test a new medicine called HI-6 DMS. Scientists want to find out if it's safe and how healthy people's bodies react to it. This medicine is being developed to help people who have been poisoned by specific chemicals known as organophosphorus compounds. They are looking at different doses given either quickly into a vein or slowly over time. This is a very early study (Phase 1), which means it's the first time this medicine is being given to humans. Your participation could help us understand if this potential new treatment is safe enough to be studied further, potentially leading to a new way to help seriously ill patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Direction Centrale Du Service De Sante Des Armees

Enrolment target

Start

20 Dec 2023

Treatment of patients poisoned with organophosphorus compounds

What is this study about?

This study is focused on a new medicine called HI-6 DMS. It's a very early-stage trial, sometimes called a Phase 1 study, which means it's the first time this particular medicine is being given to people. The main goals are to make sure it's safe and to see how the body handles different amounts of the medicine.

The medicine is being developed to treat people who have been poisoned by something called organophosphorus compounds. These are a type of chemical that can be very harmful. By carefully testing HI-6 DMS in healthy volunteers, researchers hope to learn if it could eventually become a useful treatment for those who have been poisoned.

Your involvement is really important. Even though you are healthy, your participation helps build the foundation for future studies. If this medicine proves to be safe in healthy people, it can then move on to further testing in patients who might benefit from it. This is a crucial step in bringing new, potentially life-saving treatments to those who need them.

Key takeaways

This is an early study (Phase 1) testing a new medicine, HI-6 DMS.
It's about finding out if the medicine is safe in healthy people.
The medicine is intended to treat poisoning from certain chemicals.
Participation involves receiving the medicine (or a dummy version) and health checks.
It's a chance to contribute to future medical treatments.

Who may be eligible?

To join this study, you must be a healthy adult, aged 18 or older. Both men and women are welcome to take part.

As this is a study for healthy volunteers, you should not have any serious ongoing medical conditions.

The research team will carry out several health checks to make sure you are suitable and that it is safe for you 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 18 years old or older?
Are you generally in good health?
Are you able to attend appointments at the study centre?
Are you comfortable potentially receiving a new medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, HI-6 DMS, or a dummy medicine (placebo), which looks the same but contains no active drug. This will be given either quickly into a vein (an 'IV bolus') or slowly over a period of time (an 'infusion'). You won't know whether you are receiving the active medicine or the placebo, and neither will the study team.

During your time in the study, you will have several visits to the study centre. These visits will involve various health checks, such as blood tests, heart rate monitoring, and regular checks of your overall well-being. These checks are to monitor how your body reacts to the medicine and to ensure your safety.

The total duration of your involvement, including all visits and follow-up checks, will be explained in detail by the study team, but typically for this type of early phase study, it might involve a short stay at the clinic and a few follow-up appointments.

Potential risks and benefits

The potential benefits of taking part include helping to advance medical science and possibly contributing to a new treatment for poisoning. However, since this is a first-in-human study, there are potential risks, including side effects from the study medicine which are not yet fully known. You might experience discomfort from blood tests or other procedures. The study team will closely monitor you for any side effects. You are 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
France

Common questions

What is HI-6 DMS?

It's a new medicine being developed to treat people who have been poisoned by certain chemicals.

Why is this study only for healthy people?

This is the very first time this medicine is being given to humans, so we first need to check its safety and how it works in healthy individuals before testing it in sick patients.

Will I know if I'm getting the real medicine or a dummy one?

No, neither you nor the study team will know if you are receiving the active medicine or a placebo (dummy medicine). This helps ensure fair and accurate results.

What does 'organophosphorus compounds' mean?

These are a type of chemical that can be very harmful to humans, often found in pesticides or nerve agents.

How long will I be involved in the study?

The exact duration will be explained by the study team, but typically involves a period at the clinic and some follow-up appointments.