Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, placebo-controlled, double blind, multiple ascending dose, phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of QRL-101 in healthy participants

We are inviting healthy people to take part in an important early study for a new medicine called QRL-101. This is a "Phase 1" study, which means it's one of the very first times this medicine is being given to people. Our main goals are to make sure it's safe to take, to see how people tolerate it (how they react to it), and to understand how the body processes the medicine. Participants will receive different doses of the medicine, and some will receive a dummy medicine (placebo). No one will know who is getting what until after the study, which helps us get accurate results. Your participation helps us learn vital information before the medicine can be tested in people with specific illnesses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Quralis Corp.

Enrolment target

Start

20 Jun 2024

NA - healthy volunteers

What is this study about?

This study is an early but very important step in developing a new medicine called QRL-101. Think of it like a new car model being tested in a controlled environment before it's allowed on the open road. At this stage, we aren't testing to see if the medicine treats a specific illness, but rather if it's safe for people to take at different amounts. This type of research helps doctors understand how the medicine behaves in the human body, such as how long it stays in the system and if it causes any unexpected side effects.

The study is designed as a "randomized, placebo-controlled, double-blind" trial. "Randomized" means that participants are chosen by chance to receive either QRL-101 or a placebo (a dummy medicine with no active ingredients). This ensures fairness and helps us compare the effects accurately. "Placebo-controlled" means we compare the real medicine to the dummy medicine. Both of these help us figure out if any changes are due to the medicine itself or something else. "Double-blind" means that neither the participants nor the research team will know who is receiving the real medicine and who is receiving the placebo until the study is over. This prevents anyone's expectations from influencing the results.

Participants will receive "multiple ascending doses," which means we will start with a very small dose of the medicine and gradually increase it for different groups of volunteers. This careful step-by-step approach allows us to find out how much of the medicine can be given safely without causing too many side effects. Your involvement as a healthy volunteer is incredibly valuable, as it lays the groundwork for future studies that might one day help people with illnesses.

Key takeaways

This is an early safety study for a new medicine called QRL-101.
Healthy volunteers aged 18 and older, both men and women, are needed.
The study checks for safety, side effects, and how the body processes the medicine.
You might receive the medicine or a 'dummy' medicine (placebo).
Participation helps future patients but offers no direct health benefit to you.
You can leave the study at any time.

Who may be eligible?

To join this study, we are looking for healthy people who are 18 years old or older. There is no upper age limit mentioned, so as long as you meet the other health requirements, you could be considered.

Both men and women are welcome to take part in this research. The most important thing is that you are generally in good health, as confirmed by the study doctors after some checks. Their goal is to include people who are healthy enough for the study without specific medical conditions.

Because this study involves testing a new medicine, there will be specific health checks, blood tests, and other assessments to make sure it's safe for you to participate. Even if you feel healthy, these checks help the research team confirm that you meet all the necessary requirements for the study.

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 willing to commit to multiple clinic visits?
Are you comfortable with potentially receiving a new, untested medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the clinic. These visits will involve various checks to monitor your health, such as blood pressure, heart rate, and possibly blood and urine samples. You will receive an investigational medicine, QRL-101, or a placebo, which will be given in increasing doses over time. The exact way the medicine is given (e.g., as a tablet, injection) and the schedule for taking it will be explained in detail by the study team.

Throughout the study, the research team will closely monitor you to see how you are reacting to the medicine and to check for any side effects. You might need to stay at the clinic for certain periods, especially after receiving a dose, so they can observe you carefully. After you finish taking the medicine, there will be follow-up visits to ensure your health remains good and to collect any final information. The total duration of your participation, including all visits and follow-ups, will be clearly explained before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this early-stage study, the main benefit is contributing to medical science and helping develop new medicines that could one day help others. There is no direct personal health benefit expected as this medicine is not intended to treat an existing condition in healthy volunteers. Potential risks could include side effects from the investigational medicine, which may range from mild (like headaches or nausea) to more serious, although serious side effects are rare and carefully monitored. There's also the time commitment and inconvenience of clinic visits. It's important to remember that 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.

—
Unverified
Netherlands

Common questions

What does 'Phase 1 study' mean?

A Phase 1 study is a very early stage of testing a new medicine in people, usually healthy volunteers. The main goal is to check if the medicine is safe and how the body handles it, not to treat an illness.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active ingredients. It helps us compare the effects of the actual medicine more accurately.

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

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is receiving the real medicine (QRL-101) and who is receiving the placebo until the study is finished.

Do I have to pay to join this study?

No, you should not be charged to participate in a clinical trial. Sometimes you might receive payment for your time and travel expenses, but this should be clearly explained to you.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.