Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants

This early-stage study is investigating three different forms of a new medicine called QRL-101. Researchers want to understand how these different versions behave in the bodies of healthy volunteers. They are looking at how the medicine is absorbed, how it's changed, and how it leaves the body. This information is really important because it helps scientists work out the best way to give the medicine and what dose might be most effective. Although this specific study is focused on healthy people, the medicine is being developed for a serious condition called Amyotrophic Lateral Sclerosis (ALS), a disease that affects nerve cells in the brain and spinal cord. Finding the best formulation in healthy people is a crucial step before testing the medicine in people with ALS.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Quralis Corp.

Enrolment target

Start

19 Dec 2024

Amyotrophic Lateral Sclerosis (ALS)

What is this study about?

This study is an early but very important step in developing a new medicine, QRL-101, for a serious illness called Amyotrophic Lateral Sclerosis (ALS). ALS is a condition that affects the nerves in your brain and spinal cord, which gradually makes it harder to move, speak, eat, and breathe.

In this study, researchers are giving three different versions, or 'formulations,' of the new medicine to healthy volunteers. They want to find out how each version behaves inside the body. This means understanding how quickly the medicine gets into the bloodstream, how long it stays there, and how the body eventually gets rid of it. This process is called 'pharmacokinetics.'

By comparing the three different formulations, the scientists can figure out which one is absorbed best and stays in the body in the most effective way. This information is vital because it helps them choose the best form of the medicine and the right dose for future studies, especially when they eventually test it in people who have ALS. It's a foundational step to ensure the medicine has the best chance of working safely and effectively.

Key takeaways

This study is testing different forms of a new medicine for ALS.
It's an early-stage study involving healthy adult volunteers.
The main goal is to see how the medicine moves through the body.
Both men and women aged 18 and over can potentially take part.
Participation helps scientists find the best way to give the medicine for future use.

Who may be eligible?

This study is looking for healthy volunteers aged 18 years and older. There is no upper age limit, meaning people of all adult ages can potentially take part. Both men and women are welcome to participate in this research.

Because this is an early study looking at how a medicine works in healthy people, there will be certain health checks to make sure you are in good general health. For example, people with certain ongoing medical conditions or who are taking specific medications might not be able to join, as these could affect how the study drug works or could put their health at risk.

When you speak to the study team, they will ask you detailed questions about your health and medical history, and you may have some basic medical tests. This is all to make sure the study is safe for you and that the results they get from your participation are clear and accurate.

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 willing to discuss your full medical history with the study team?
Are you able to commit to the study visits and procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be one of the healthy volunteers helping researchers understand a new medicine. While the detailed steps aren't provided, typically in these types of studies, you would:

* **Have an initial screening visit:** This involves health checks, a review of your medical history, and some basic tests (like blood tests or an ECG) to confirm you are healthy enough to participate. * **Stay at a clinic or visit regularly:** You would likely receive one of the three different forms of the QRL-101 medicine. After receiving the medicine, you would have several blood samples taken over a set period (which could be hours or days) to measure how the medicine moves through your body. You might also have other assessments, such as checking your vital signs (blood pressure, heart rate). * **Follow-up visits:** After the main part of the study, there might be one or more follow-up appointments to ensure you are well and to check for any lasting effects. * **Total duration:** The overall time commitment for participation varies greatly but could range from a few days to a few weeks, including screening and follow-up. You will be given all the specific details before you agree to join.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and risks. One potential benefit of taking part in this early-stage research is knowing you are contributing to science and the development of potential future treatments for serious conditions like ALS. However, as this is an early trial of a new medicine, there might be unknown side effects or discomfort. The study staff will explain all known potential risks, such as temporary side effects like nausea or headaches, or reactions at the injection site if the medicine is given by injection. You have the right 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.

—
Unverified
Netherlands

Common questions

What is ALS?

ALS stands for Amyotrophic Lateral Sclerosis. It's a serious disease that affects the nerve cells in your brain and spinal cord, making it progressively harder for you to move, speak, and breathe.

What does 'pharmacokinetics' mean?

Pharmacokinetics is how your body handles a medicine. It's about how much of the medicine gets into your system, how it's changed by your body, and how quickly it leaves your body.

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how the medicine works in a typical body without the complications of an illness. This is an important step before testing the medicine in people who are sick.

Will I get the medicine for ALS in this study?

No, this study is about understanding how different versions of the medicine behave in healthy bodies. You won't be treated for ALS, as you must be healthy to join this particular study.

Will I be paid for taking part?

Many early-stage clinical studies offer some payment for your time and travel, but this varies. You should ask the study team about this directly.