Active not recruitingPHASE1INTERVENTIONAL

A Study of SPY003-207 in Healthy Volunteers

This research study is looking at a new medicine called SPY003-207. It's the very first time this medicine will be given to people. The main goal is to check its safety and see how well healthy people can tolerate it. We also want to understand how the medicine travels through the body. Participants will be randomly assigned to either receive the new medicine or a dummy pill (placebo) without knowing which one they are getting. This is a common way to test new medicines and help us learn if they might be helpful for future treatments. Your involvement helps us gather important information for healthcare advancements.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Spyre Therapeutics, Inc.

Enrolment target

Start

10 Mar 2025

Estimated completion

18 Nov 2026

Healthy

What is this study about?

Imagine scientists have developed a brand-new car engine, but they need to make sure it works safely before putting it into general use. Clinical trials are a bit like that for medicines. This particular study is the very first step, called a Phase 1 trial, where we introduce a new medicine, SPY003-207, to a small group of healthy people. We're not treating a specific illness yet; instead, we're carefully watching how the body reacts to this new substance.

Our main goals are to find out if the medicine is safe, what dose healthy people can tolerate without serious problems, and how it behaves inside the body – for example, how quickly it's absorbed and removed. To make sure our results are reliable, some participants will receive the actual medicine, and others will get a 'placebo' which looks identical but contains no active medicine. Neither you nor the study team will know who is getting what, which helps us get unbiased information.

Taking part in studies like this is crucial because it helps us understand new medicines from the ground up. The information we gather will help guide whether this medicine can move to later stages of testing, where it might be given to people with specific health conditions. Your participation, if you choose to join, directly contributes to scientific knowledge that could potentially lead to new treatments in the future.

Key takeaways

This study is testing a new medicine (SPY003-207) in healthy people for the first time.
The main goals are to check for safety, how much the body tolerates, and how the medicine moves through the body.
Participants will either get the new medicine or a dummy pill (placebo).
You'll need to visit a study centre for checks, and some visits might involve staying there.
Your participation helps advance medical science.
You can stop taking part at any time without affecting your normal healthcare.

Who may be eligible?

To be considered for this study, you need to be a healthy man or woman between 18 and 60 years old. It's important that you're willing and able to come to all the required appointments at our study centre, stay for the necessary periods, and return for any follow-up visits.

There are also some reasons why you might not be able to join. For example, if you've already taken part in another study at the same time, or if you have any significant health issues or diseases that our doctors spot during your check-up. We also can't include people with a history of serious allergies, or those who use recreational drugs, misuse alcohol, or have smoked or used nicotine products in the last three months.

Lastly, if you've recently donated a lot of blood (more than one pint) in the month leading up to the study, you wouldn't be able to participate. These rules are in place to help keep you safe and to make sure the study results are as clear and accurate as possible.

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 between 18 and 60 years old?
Are you generally healthy?
Can you commit to all required visits and stays at the study centre?
Have you avoided serious allergies or severe reactions in the past?
Have you not smoked, used recreational drugs, or misused alcohol in the last 3 months?
Have you not donated more than one pint of blood in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will need to attend several visits at our research centre. Some of these visits will involve staying at the centre for a period of time, which we call a 'confinement period'. This allows our team to closely monitor you after you receive the study medicine or placebo.

During these visits, we will carry out various assessments. This typically includes physical examinations, blood tests, and other checks to see how you are responding to the medicine. You will receive either a single dose of the new medicine, SPY003-207, or a dummy pill (placebo) as a one-off treatment.

After you've received the medicine and completed your stay at the centre, you will need to return for a few outpatient visits. These follow-up appointments allow us to continue monitoring your health and see if there are any delayed effects. The total duration of your participation in the study, from your first visit to your final follow-up, will be explained in detail before you agree to join.

Potential risks and benefits

While there are no direct health benefits for you from taking part in this early-stage study, your participation is incredibly valuable. The information gathered helps scientists understand new medicines better, which could lead to new treatments for others in the future. As with any medicine, there is a chance of side effects, which could range from mild to more serious, and these will be carefully monitored by our medical team. All potential risks will be thoroughly explained to you, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Spyre Site 2
Verified postcode
Cypress, United States
Spyre Site 1
Verified postcode
Montreal, Canada

Common questions

What is a 'Phase 1' study?

It's the first time a new medicine is given to people. The main goals are to check if it's safe, how much the body can handle, and how it works inside the body.

What does 'randomised' mean?

It means you'll be put into a group by chance – either getting the active medicine or a dummy pill (placebo). It's like flipping a coin, so it's fair.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It helps us see the true effect of the actual medicine.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study team will know. This is called 'double-blind' and helps ensure that everyone's symptoms and responses are assessed without bias.

Will I get paid for taking part?

Some studies offer payment for your time and inconvenience. This will be fully explained before you agree to take part.