RecruitingPHASE1INTERVENTIONAL

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants

This study is testing a new medicine called LY4066708 for the first time in healthy people. The main goals are to make sure it's safe and to understand if it causes any side effects. Researchers will also be checking how the body processes the medicine – how much gets into the bloodstream and brain, and how quickly it leaves the body. This is a Phase 1 study, which means it's one of the earliest steps in developing a new medicine. Participants will be involved for up to 24 weeks. The information gathered from healthy people helps doctors decide if the medicine can be tested in patients with specific conditions, such as cancer, in the future. Your involvement helps advance medical science.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

104

Start

13 May 2025

Estimated completion

01 Sep 2027

Healthy Cancer

What is this study about?

This study is looking at a new medicine called LY4066708. When a new medicine is developed, the first step is often to test it in a small group of healthy volunteers. This helps doctors learn about the medicine in a safe and controlled way before it's given to people who are unwell. This particular study is called a 'single and multiple-ascending dose study'. This means some participants will receive one dose, and others will receive more than one dose over time. The 'ascending' part means the doses might gradually increase, but this is always done very carefully.

The main aim of this study is to check how safe the medicine is and if it causes any side effects. This is really important. The study also wants to understand how your body handles the medicine – for example, how much of it gets into your blood and the fluids around your brain and spinal cord, and how long it takes for your body to get rid of it. This process is called 'pharmacokinetics'. By understanding this, doctors can work out the best doses to use in future studies.

Even though you might be healthy, your participation is very valuable. The information from this study will help researchers decide if LY4066708 can be tested further in people with certain health problems, like cancer. Without studies like this, new medicines can’t be developed.

Key takeaways

Tests a new medicine, LY4066708, primarily for safety and side effects.
Participation is for healthy individuals, aged 18-65.
Involves regular clinic visits, blood tests, and heart monitoring.
Some participants may receive a placebo (dummy medicine).
Some participants will have 'lumbar punctures' to collect fluid from their spine.
Participation lasts up to 24 weeks.

Who may be eligible?

To join this study, you need to be generally healthy. This means that doctors will check your medical history, do a physical exam, and run some tests on your blood and heart to make sure you're suitable. You also need to be aged between 18 and 65 years old. Your body mass index (BMI), which is a measure relating your weight to your height, needs to be between 18.5 and 30.

There are also some things that would mean you couldn't take part. For example, if you're pregnant or breastfeeding, you wouldn't be able to join. If you have a history of certain heart problems, specific allergies to the study medicine, or if you've taken part in another drug trial recently (within the last three months), you wouldn't be eligible. Also, if you've been in this very study before, you can't join again.

For women who could become pregnant, you would need to agree to use effective contraception throughout the study. The same goes for men. Additionally, a small number of participants will need to be of Japanese or Chinese descent, as specifically defined by their family's birthplaces.

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 generally healthy, with no major ongoing medical conditions?
Are you between 18 and 65 years old?
Is your BMI (body mass index) between 18.5 and 30?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study?
Have you avoided taking part in other drug trials in the last 3 months?
Are you willing to have regular blood tests and possibly a lumbar puncture?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for up to 24 weeks in total. Over this time, you would have several visits to the clinic. At these visits, doctors and nurses will carry out checks on your health, including physical examinations, blood tests, and heart monitoring (like an ECG).

You would receive either the study medicine, LY4066708, or a placebo. A placebo is a dummy medicine with no active ingredients, and it looks just like the real medicine. Which one you receive is decided by chance, like flipping a coin, and neither you nor the study team will know until after the study is complete. This helps to fairly compare the effects of the medicine.

Some participants will also need to have repeated 'lumbar punctures'. This is a procedure where a very fine needle is used to collect a small sample of fluid from around your spinal cord, usually from your lower back, to see how much of the medicine gets there. The study team will explain everything to you in detail before you agree to anything, and you'll have plenty of chances to ask questions.

Potential risks and benefits

Taking part in a study like this doesn't directly offer a medical benefit to you personally, as you are healthy. However, you would be contributing to valuable medical research that could help develop new treatments for others in the future. The risks involve potential side effects from the study medicine, which are usually mild but can sometimes be more serious. There's also the discomfort from blood tests and, for some, the lumbar puncture procedure. The study team will explain all known risks to you in detail. 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.

Fortrea Clinical Research Unit
Unverified
Holbeck, Leeds, United Kingdom· Recruiting

Common questions

What is LY4066708?

It's a new medicine being tested for the first time in people. We don't know yet what it might be used for, beyond the conditions mentioned like cancer. This study is about understanding its basic safety and how it works in the body.

What does 'Phase 1 study' mean?

It means this is one of the very first studies of a new medicine in people. It mainly focuses on safety, side effects, and how the body handles the medicine, using a small number of participants.

Will I definitely get the actual medicine?

Not necessarily. In this study, some people will receive the new medicine, and others will receive a 'placebo', which is a dummy medicine without any active ingredients. You won't know which one you're getting.

What is a 'lumbar puncture'?

It's a procedure where a thin needle is used to collect a small amount of fluid from your lower back. This helps doctors see how much of the medicine gets into the fluid surrounding your brain and spinal cord.

How long will I be involved in the study?

Each participant will be involved in the study for a total of up to 24 weeks.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.