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

A single and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZP-3813, a growth hormone antagonist, in healthy subjects

This is an early-stage medical study, often called a Phase I trial. It's investigating a new medication, AZP-3813, which is designed to help with a condition called acromegaly. Acromegaly happens when the body produces too much growth hormone. In this study, researchers are giving AZP-3813 to healthy volunteers, not people with acromegaly. They want to carefully check a few things: firstly, if the medicine is safe and if people can tolerate it without too many side effects; secondly, how the body absorbs, distributes, and gets rid of the medicine; and thirdly, if the medicine has its expected effects on the body. This is the very first time this particular medicine will be given to humans, so it's a crucial step in understanding future treatments for acromegaly.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Amolyt Pharma, Amolyt Pharma

Enrolment target

101

Start

24 Apr 2023

Acromegaly

What is this study about?

You might be seeing information about a new research study. This study is about a potential new medicine called AZP-3813. It's designed to help people who have a condition called acromegaly. Acromegaly happens when your body makes too much 'growth hormone'. This extra hormone can lead to various health problems over time, like changes in your appearance, joint pain, and an increased risk of other health issues.

This particular study is a very early step in checking new medicines, often called a ‘Phase I’ study. Think of it like a first careful test drive. Before a new car can be sold, it undergoes many safety checks. Similarly, before a new medicine can be given to people with a specific illness, researchers need to understand how it works and whether it's safe in healthy people. This study is focused on healthy volunteers, not people who currently have acromegaly.

The main goals are to see if the medicine is safe when given to people for the first time, how much someone can take without problems, how the body handles the medicine (like how quickly it enters and leaves the body), and if it has the intended effects on the body’s systems. This information is really important because it helps scientists decide if the medicine is promising enough to be studied further in people who actually have acromegaly.

Key takeaways

This is an early-stage study for a new acromegaly medicine.
It's testing a medicine called AZP-3813 for the first time in humans.
The study is looking at safety, how the body handles the medicine, and its effects.
Only healthy adult volunteers can participate.
It's a crucial step to see if the medicine is safe enough for future testing.
Participation helps advance potential treatments for acromegaly.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old. There isn't an upper age limit mentioned, but the research team will explain if there are any other age considerations. The study is open to both men and women.

Because this is a study involving a new medicine given for the first time to people, the researchers will be very careful. They will need to make sure you are generally in good health and don't have any medical conditions that might make it unsafe for you to take part or affect the study's results. They will likely do thorough health checks, including blood tests and possibly other examinations, to confirm you are healthy enough.

It’s important to remember that even if you meet the basic age and sex requirements, there might be other reasons why you wouldn't be able to join. For example, if you are taking certain medications or have specific health conditions, you might not be eligible. The study staff will carefully go through all the criteria with you.

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 commit to repeated visits or stays at the clinic?
Are you comfortable potentially taking an experimental medicine?
Are you not currently pregnant or breastfeeding (if applicable)?
Are you willing to avoid certain medications or activities during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this type of study, you would first have a screening visit. This is where medical staff check your health to make sure you are suitable for the study. If you are eligible, you would likely spend some time at the clinic or hospital, perhaps for a few days or longer, especially when you first receive the study medicine.

During your time in the study, you would be given the AZP-3813 medicine. This might involve taking a single dose, or perhaps multiple doses over a period. Researchers would closely monitor you for any side effects and take regular measurements. These could include blood samples to see how the medicine is moving through your body, and other tests to see if it's having its intended effects. You would have several follow-up visits after taking the medicine to ensure you are well and to collect more information. The total duration of your participation, including screening, dosing, and follow-up, would be clearly explained to you.

Potential risks and benefits

Participating in any medical study has potential benefits and risks. A potential benefit of this study is that you would be contributing to scientific knowledge that could lead to new treatments for acromegaly in the future. You would also receive careful medical monitoring throughout your participation. However, there are potential risks, especially since this is a new medicine being given to humans for the first time. There could be side effects that are not yet known, ranging from mild (like headache or feeling tired) to more serious ones. The research team will carefully explain all known risks. Remember, your participation is completely 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 acromegaly?

Acromegaly is a health condition where the body makes too much growth hormone, leading to gradual changes in appearance and other health problems.

Why is this study giving the medicine to healthy people?

Because this is a very new medicine, researchers first need to understand how it works and if it's safe in healthy people before testing it in patients with acromegaly.

Will I get paid for participating?

Sometimes studies offer payment for your time and travel, but this varies. You should ask the study team if compensation is provided.

What does 'single and multiple ascending dose' mean?

It means some participants will get one dose, while others will get several doses. 'Ascending' means they'll start with very low doses and increase them slowly to find the safest and most effective amount.

What are 'pharmacokinetics' and 'pharmacodynamics'?

Pharmacokinetics is how your body handles the medicine (absorbs, distributes, gets rid of it). Pharmacodynamics is what the medicine does to your body.