Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics and Safety of ANT3310 Combined with Meropenem Administered as a Single Intravenous Infusion to Adult Subjects with Renal Function Impairment

This study is testing a new drug called ANT3310, in combination with a common antibiotic called Meropenem. The main goal is to understand how these medicines move through the body and how quickly they are removed, especially in adults who have kidney problems. Researchers also want to check if the new drug combination is safe. This is a very early study (Phase 1), which means it's one of the first times this specific combination is being given to people. It involves a single dose given intravenously (into a vein) and observing participants in one location. This research is important for finding safer ways to treat infections in people with reduced kidney function.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Antabio

Enrolment target

Start

12 Jun 2024

Renal impairment

What is this study about?

This study is focused on a new medicine, ANT3310, which will be given alongside an antibiotic called Meropenem. Meropenem is a well-known antibiotic used to treat serious infections. The main purpose of this research is to see what happens to these medicines once they enter the body. Researchers want to understand how the body absorbs them, breaks them down, and gets rid of them, particularly in adults who have problems with their kidneys. Kidneys are vital for filtering waste and medicines from the blood, so understanding how they handle new treatments is very important.

The study also aims to check the safety of this new medicine combination. Because it's a 'Phase 1' study, it means it's an early step in testing a new drug in humans. This trial will help us learn if the new combination is safe enough to be studied further in a larger number of people. The information gathered will be crucial for developing better and safer treatments for infections, especially for patients whose kidneys aren't working as well as they should.

Ultimately, this research helps doctors develop a better understanding of how dosages of new medicines might need to be adjusted for people with kidney issues, ensuring they receive the right amount of medicine that is both effective and safe. It's a key step in bringing new, potentially life-saving treatments to patients.

Key takeaways

Tests a new drug (ANT3310) with an existing antibiotic (Meropenem).
Focuses on how the body handles the drugs in adults with kidney problems.
Aims to check the safety of this new combination.
It's an early-stage study (Phase 1).
Involves a single dose given into a vein.
Contributes to understanding safer treatments for people with kidney issues.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over. Both men and women can take part. A key requirement is that you must have some level of kidney function impairment, which means your kidneys aren't working as well as they normally would.

Further details about specific health conditions or medications you might be taking would be discussed in full by the study team. They will carry out checks to make sure this study is right and safe for you to join.

It's important to remember that having a condition listed for the study doesn't automatically mean you can participate; there are usually other health checks to ensure your safety.

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 have some form of kidney problem or impairment?
Are you able to visit a study centre for assessments?
Are you willing to have an intravenous infusion (medicine into a vein)?
Are you able to provide regular blood and potentially urine samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will go through a screening process to make sure it's safe and suitable for you. This will involve some medical tests and checks. If you are eligible, you will receive a single dose of the study medication, which is ANT3310 combined with Meropenem, given directly into a vein (an intravenous infusion).

You will need to stay at the study centre for a period of time after receiving the medication so that the researchers can closely monitor you. They will take blood samples and possibly urine samples at specific times to see how your body processes the medicine. They will also regularly check your vital signs, like blood pressure and heart rate, and ask about any side effects you might experience. The total duration of your active participation, including assessments and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could lead to improved treatments for people with kidney problems and infections in the future. You will also receive careful medical monitoring. However, there are potential risks, including side effects from the study medication, which could range from mild discomfort (like pain at the injection site) to more serious reactions. All known risks will be thoroughly explained to you, and new risks could emerge. 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
Germany

Common questions

What does 'Phase 1' mean?

Phase 1 means this is an early study, often one of the first times this drug combination is being tested in people. It mainly focuses on safety and how the body handles the medicine.

What is Meropenem?

Meropenem is a well-established antibiotic used to treat serious bacterial infections. In this study, it's being given with a new medicine called ANT3310.

What are 'renal function impairment' and 'kidney problems'?

These terms both refer to situations where your kidneys are not working as well as they should, meaning they don't filter waste from your blood as effectively.

Will I have to stay overnight?

The study involves a single dose given into a vein, followed by monitoring. You will need to stay at the study centre for a period, potentially overnight, for close observation. The exact duration will be explained by the study team.

Will I be given the new drug?

Yes, if you meet the study criteria, you will receive a single dose of the new drug ANT3310 along with Meropenem.