AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A PHASE 1 STUDY WITH SINGLE ASCENDING DOSE, MULTIPLE ASCENDING DOSE AND FOOD EFFECT OF LMT503 IN HEALTHY SUBJECTS.

This is a very early, small study for a new medicine called LMT503. Researchers are giving this medicine to healthy volunteers for the very first time to understand more about it. We want to find out how safe LMT503 is, what the right dose might be, and how the body uses it up and gets rid of it. The study will also check if eating food before taking the medicine changes how it works in the body. This kind of study is important for making sure new medicines are safe before they can be tested in people who are unwell.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Lmito Therapeutics Inc.

Enrolment target

Start

25 Nov 2024

Healthy volonteers

What is this study about?

Imagine a brand new car model that's just been built for the first time. Before anyone can drive it on the roads, engineers need to test it thoroughly in a controlled environment to make sure it's safe and that all the parts work as they should. This study is a bit like that, but for a new medicine called LMT503.

This is a 'Phase 1' study, which is the very first step in testing a new medicine in humans. Instead of people with a specific illness, healthy volunteers are taking part. This is because at this early stage, the main goal is to understand how the medicine behaves in the human body itself, without the complications of an existing health problem. Researchers want to see how much of LMT503 can be given safely, what side effects might occur, and how the body processes the medicine – how it's absorbed, distributed, and eventually leaves the body.

An important part of this study also involves looking at the 'food effect'. This means researchers will check if taking LMT503 with food makes a difference to how your body absorbs or uses it, compared to taking it on an empty stomach. This information is really important for future studies and figuring out the best way for patients to take the medicine if it moves on to later stages of testing.

Key takeaways

This is a safety study for a new medicine called LMT503.
Healthy volunteers aged 18 and over are needed.
It's a 'first-in-human' study, gathering basic information.
Researchers will check how the body handles the medicine and if food changes its effects.
Participation helps future medical research, but offers no direct health benefit to you.

Who may be eligible?

To take part in this study, you need to be a healthy adult. This means you generally feel well and don't have any serious ongoing health conditions that could affect how the medicine works or put you at extra risk.

There's no upper age limit, meaning as long as you meet the other health criteria, you can be considered. You must be at least 18 years old to join.

Both men and women are welcome and can take part in this study, provided they meet all the other requirements.

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 at least 18 years old?
Do you consider yourself generally healthy?
Are you able to follow study instructions carefully?
Are you comfortable with regular health checks, including blood tests?

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 make sure you're suitable. If eligible, you'll receive the study medicine, LMT503, either as a single dose or repeated doses over a short period. You’ll be closely monitored by doctors and nurses, and they will regularly check your health, take blood and urine samples, and ask about any side effects. Some visits might involve staying at a clinic overnight. For the 'food effect' part, you might take the medicine with or without a meal. The total time you'll be involved in the study, including follow-up visits after you've taken the medicine, will be explained to you before you agree to participate.

Potential risks and benefits

As this is an early study of a new medicine, there are no known direct health benefits to you for taking part. However, your participation will help researchers learn more about LMT503, which could potentially help others in the future. Potential risks include experiencing side effects from the medicine, which could range from mild discomfort to more serious reactions, although every precaution is taken to minimise these. You have the right to withdraw from the study at any time, for any reason, without 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 does 'Phase 1' mean?

Phase 1 means this is the very first time this new medicine is being tested in humans, usually in healthy volunteers, to check safety and how the body handles it.

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how the medicine works in the body without other health conditions making it complicated.

What is 'LMT503'?

LMT503 is the name of the new experimental medicine being tested in this study.

Will I get better if I take part?

This study is for healthy people and is not expected to make you 'better,' as it's not looking to treat an illness.

What does 'food effect' mean?

It means the study will check if taking the medicine with or without food changes how your body uses it.