RecruitingPHASE1INTERVENTIONAL

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

This research study is looking into a new medicine called AMG 691. It's a 'Phase 1' trial, which means the main goal is to find out if the medicine is safe and how well people tolerate it, rather than focusing on how well it treats asthma right now. Researchers will give AMG 691 to both healthy volunteers and people who have mild-to-moderate asthma. They will start by giving single doses to healthy volunteers and then move on to multiple doses for both groups. The team will carefully check for any side effects and see how the body handles the new medicine. This essential first step helps decide if the medicine can be tested further in larger studies.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Amgen

Enrolment target

124

Start

16 Oct 2024

Estimated completion

07 Jun 2027

Asthma

What is this study about?

This study is an early-stage clinical trial focused on a new medicine called AMG 691. When a new medicine is developed, it goes through different phases of testing. This is a Phase 1 study, which means the main goal is to make sure the medicine is safe for people to take and to understand how the body reacts to it, rather than measuring how well it treats a condition right away. Think of it as the very first step in checking out a new treatment.

The researchers will be giving AMG 691 to two main groups of people: healthy volunteers and people who have mild-to-moderate asthma. They will be looking very closely at any side effects and how the body processes the medicine after single doses and then multiple doses. This information is really important because it helps scientists decide if the medicine is safe enough to continue with more advanced studies that would then look at how well it works for treating asthma symptoms.

Taking part in a study like this helps advance medical science. New treatments can only become available if they are first carefully tested for safety and understanding in clinical trials. Your participation, if you choose to, could help pave the way for future asthma treatments.

Key takeaways

This is a safety study for a new medicine called AMG 691.
It involves healthy volunteers and people with mild-to-moderate asthma.
You might receive the new medicine or a dummy medicine (placebo).
Participation includes regular clinic visits for various health checks.
The main goal is to find out if the medicine is safe for people to take.
You can stop participating at any time you wish.

Who may be eligible?

This study is looking for two main types of people: healthy volunteers and people with mild-to-moderate asthma.

Healthy volunteers need to be between 18 and 65 years old, generally healthy, and have a healthy weight. For women, you must no longer be able to have children. If you have a serious medical condition, you might not be able to join.

If you have mild-to-moderate asthma, you need to be aged 18 to 70 and have been diagnosed with asthma for at least a year. You should have a certain level of lung function, and your asthma should respond to bronchodilator medicines. You might be on inhalers, but these need to be stable for at least 12 weeks. People who have had certain cancers or serious allergic reactions might not be able to take part.

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 70 years old?
Do you have a healthy weight (BMI between 18 and 35, and weight at least 40kg)?
If you're a woman, are you past childbearing age or unable to have children?
If you have asthma, has it been diagnosed for at least 12 months?
Do you have mild-to-moderate asthma and good enough lung function?
Have you had no serious cancers or major allergic reactions in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have some screening tests to check if you're suitable. Once enrolled, you'll receive either the new medicine, AMG 691, or a 'placebo', which is a dummy medicine with no active ingredients. This is a "double-blind" study, meaning neither you nor the study team will know if you're getting the active drug or the placebo.

You will have several scheduled visits to the study clinic. These visits will involve various assessments, such as physical exams, blood tests, urine tests, and lung function tests if you have asthma. These tests help the researchers understand how your body is reacting to the medicine and if there are any side effects. You will be closely monitored by the study team.

The total duration of your participation in the study will depend on which part of the study you are in, but it will involve several weeks of treatment and follow-up. You'll be given detailed information about the schedule of visits and procedures if you consider joining.

Potential risks and benefits

Participating in an early-stage study like this means that the potential benefits to you directly are uncertain, as the main goal is to test safety and not yet to treat your condition. However, you would be contributing valuable information that could help develop future treatments for asthma. As with any medicine, there are potential risks, including side effects from the study drug. These can range from mild to more serious, and the study team will monitor you closely for any reactions. You will receive detailed information about all known potential risks before you decide to join. It's very important to remember that participating is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Orange County Research Center
Verified postcode
Lake Forest, United States· Recruiting
Translational Clinical Research LLC
Verified postcode
Aventura, United States· Recruiting
Destiny Research Center
Verified postcode
Palmetto Bay, United States· Recruiting
ClinCept, LLC
Verified postcode
Columbus, United States· Completed
Chesapeake Clinical Research Inc
Verified postcode
White Marsh, United States· Recruiting
Brigham and Womens Hospital
Verified postcode
Boston, United States· Recruiting
Mayflower Clinical
Verified postcode
South Dartmouth, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Prism Research LLC dba Nucleus Network
Verified postcode
Saint Paul, United States· Recruiting
University of North Carolina Clinical and Translational Research Center
Verified postcode
Chapel Hill, United States· Recruiting
Monroe Biomedical Research
Verified postcode
Monroe, United States· Recruiting
North Carolina Clinical Research
Verified postcode
Raleigh, United States· Recruiting

Common questions

What is a 'Phase 1' study?

Phase 1 is the first stage of testing a new medicine in people. The main aim is to check if it's safe and to understand how the body handles it, rather than to see if it treats a disease yet.

What is AMG 691?

AMG 691 is a new medicine being developed. This study aims to learn about its safety and how people tolerate it.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers compare the effects of the new medicine.

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

No, this is a 'double-blind' study, meaning neither you nor the study team will know whether you're receiving AMG 691 or the placebo until after the study is over.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can decide to leave the study at any point without it affecting your regular medical care.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

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