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

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE I STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ANDMULTIPLE ASCENDING DOSES OF THN391 IN HEALTHY SUBJECTS

We're inviting healthy volunteers to take part in an important early-stage study for a new medicine called THN391. This is a "Phase I" study, meaning it’s the very first time this new medicine will be given to people. The main goals are to check if THN391 is safe, how well people tolerate it, and how the body processes it after taking a single dose and then multiple doses. Some participants will receive the active medicine, while others will receive a dummy treatment (placebo) – neither you nor the study team will know which you are getting. This helps us understand the medicine's effects more clearly. Your participation could help us learn more about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Therini Bio Inc.

Enrolment target

Start

15 Oct 2024

Healthy volunteers

What is this study about?

This study is a very early step in developing a new medicine called THN391. Think of it like taking a new car design from the drawing board to the first test drive. In this "Phase I" study, we're not yet trying to treat a specific illness. Instead, the main focus is on safety. We want to make sure THN391 can be given to people without causing serious problems.

We'll be looking at how the body reacts to the medicine and how it moves through your system. This includes how much of the medicine gets into the blood, how long it stays there, and how the body gets rid of it. Understanding these things is crucial before we can test the medicine in people who are unwell.

Some volunteers will receive THN391, and others will receive a placebo, which looks exactly like the medicine but contains no active ingredients. This is a common and important way to fairly compare the effects of the new medicine. Neither you nor the study doctors will know who is getting what until the study is over. This helps ensure the results are unbiased and reliable.

Key takeaways

This is an early-stage study (Phase I) of a new medicine called THN391.
The main aims are to test its safety and how the body processes it in healthy volunteers.
Participants will receive either the new medicine or a dummy treatment (placebo).
Neither you nor the study team will know which treatment you are getting.
You must be a healthy adult, aged 18 or over, to be considered.
Your involvement could help advance medical research, but personal health benefits are not expected.

Who may be eligible?

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

Being "healthy" usually means you don't have any major ongoing medical conditions, you're not taking certain regular medications, and your general health is good. During the screening process, the study team will ask you questions about your medical history and do some health checks to make sure this study is right and safe for you.

It's important to remember that even if you meet the basic age and health requirements, there might be other specific criteria that determine if you can participate. This will be discussed in detail by the study team.

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 study visits at the clinic?
Are you comfortable potentially receiving a placebo?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. If you are, the study will involve several visits to the clinic over a period of time. You'll receive either the new medicine (THN391) or a placebo, given as a single dose first, and then possibly multiple doses later on according to the study plan. You won't know which one you are receiving.

During your visits, the study team will carry out various assessments. This typically includes physical exams, blood tests, urine tests, and monitoring your vital signs like blood pressure and heart rate. These checks help us understand how your body is reacting to the medicine. There will also be follow-up visits or calls after you've finished taking the medication to ensure you remain well. The total duration of your involvement, including all visits and follow-ups, will be explained fully by the study team.

Potential risks and benefits

As this is a very early study in humans, the main potential benefit isn't to your personal health, but rather the opportunity to contribute to medical science and help us understand if a new medicine can be developed. There's always a possibility of side effects with any new medicine, ranging from mild (like a headache or feeling tired) to more serious, though these are carefully monitored. The study team will explain all known and possible potential risks to you before you agree to take part. 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
Netherlands

Common questions

What is a Phase I study?

It's the very first time a new medicine is given to people. The main goal is to check if it's safe and how the body handles it, rather than treating an illness.

What does 'double-blind' mean?

It means neither you nor the study team will know if you're receiving the active medicine or a dummy treatment (placebo). This helps make the study fair and unbiased.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the new medicine.

Will I get paid for taking part?

This is a common question, and any potential payment for your time and expenses will be discussed by the study team if you are eligible and interested.

What if I change my mind?

You are absolutely free to withdraw from the study at any point, for any reason, without it affecting your future medical care.