Active not recruitingPHASE1INTERVENTIONAL

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

This research study is looking at a new investigational medicine called GSK3862995B. We want to understand if it's safe and how well people tolerate it. The study will first give single, small doses to healthy volunteers. Then, it will give repeated doses to people living with Chronic Obstructive Pulmonary Disease (COPD). We'll be closely monitoring for any side effects or problems to make sure the medicine is safe. This is a very early stage of testing, known as 'Phase 1', which focuses purely on safety before looking at how well a medicine works. Participating in such studies helps scientists learn more about new potential treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

127

Start

27 Nov 2023

Estimated completion

17 Dec 2026

Pulmonary Disease, Chronic Obstructive

What is this study about?

This study is about a new medicine called GSK3862995B, which is being developed for people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a common lung disease that makes it hard to breathe. Before any new medicine can be used more widely, it must go through careful testing to make sure it's safe.

This particular study is a very early stage of testing, often called 'Phase 1'. The main goals are to find out if GSK3862995B is safe and how well people tolerate it. This means we'll be looking carefully for any side effects or problems. We'll start by giving single, small doses to healthy volunteers to see what happens. If that goes well, we'll then give repeated doses to people who have COPD.

Understanding safety is the most important first step. If the medicine proves to be safe, then future studies can look at whether it actually helps improve COPD symptoms. Your participation, whether healthy or with COPD, helps researchers gather vital information to potentially develop new and better treatments for lung conditions.

Key takeaways

This study is testing a new medicine (GSK3862995B) for safety in healthy people and those with COPD.
It's a very early ('Phase 1') study, focused on understanding side effects and how the medicine is tolerated.
Participants will receive either the new medicine or a dummy medicine (placebo).
Close medical supervision and various tests will be part of the study.
Your participation helps advance research into new COPD treatments.

Who may be eligible?

This study is looking for two main groups of people: healthy volunteers and people with COPD. For healthy volunteers, you need to be generally healthy, aged between 18 and 65, and weigh between 50 and 110 kilograms. If you're a woman, you must not be able to have children (for example, if you've had a hysterectomy or are past menopause).

If you have COPD, you need to be between 40 and 75 years old, also weigh between 50 and 110 kilograms, and have a confirmed diagnosis of COPD for at least 12 months. Your COPD needs to be managed with your usual inhaler medicines. We'll also check your lung function and a specific type of white blood cell count. You can be a former smoker, a current smoker (including e-cigarettes), or someone who has never smoked.

There are also some reasons why you might not be able to join. For example, if you have other health conditions that aren't well-controlled, or if you've had certain infections recently, the study might not be suitable for you. The study doctors will carefully check all your health information to make sure it's safe for you 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 65 (healthy) or 40 and 75 (COPD)?
Do you weigh between 50kg and 110kg?
If you have COPD, has it been diagnosed for at least a year?
Do you currently manage your COPD with regular inhalers?
Are you a woman who cannot have children, or a man?
Do you have any other serious, uncontrolled health conditions?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive either the new study medicine, GSK3862995B, or a dummy medicine called a placebo. A placebo looks just like the real medicine but contains no active drug. This helps us fairly compare the effects. You wouldn't know whether you're getting the active medicine or the placebo.

For healthy volunteers, you would likely receive a single dose. For those with COPD, you would receive several doses over a period. Throughout your participation, you would have several visits to the study clinic. These visits will involve various health checks, such as physical exams, blood tests, urine tests, heart monitoring (like ECGs), and lung function tests if you have COPD. The doctors and nurses will closely monitor you for any side effects.

There will also be follow-up appointments after you've finished taking the medicine to make sure you remain well. The total time you would be involved in the study, from your first screening visit to your last follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from this study, as its main purpose is to test the safety of a new medicine, not necessarily to treat your condition. However, by participating, you help scientists learn more about new potential treatments for COPD, which could benefit others in the future. Potential risks include experiencing side effects from the study medicine, which could be mild or, in rare cases, more serious. There might also be discomfort from tests like blood draws or lung function measurements. You will receive very careful medical attention and monitoring throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (32)

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

GSK Investigational Site
Verified postcode
Yuma, United States
GSK Investigational Site
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Hialeah, United States
GSK Investigational Site
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Orange City, United States
GSK Investigational Site
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Plantation, United States
GSK Investigational Site
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Columbus, United States
GSK Investigational Site
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Shelby, United States
GSK Investigational Site
Verified postcode
Medford, United States
GSK Investigational Site
Verified postcode
Philadelphia, United States
GSK Investigational Site
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Rock Hill, United States
GSK Investigational Site
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Austin, United States
GSK Investigational Site
Verified postcode
Ahrensburg, Germany
GSK Investigational Site
Verified postcode
Berlin, Germany

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually due to long-term exposure to harmful gases or particles, often from smoking.

What is a 'Phase 1' study?

Phase 1 is the first stage of testing a new medicine in humans. The main goal is to find out if the medicine is safe, how it behaves in the body, and what dose might be appropriate, rather than focusing on how well it treats a disease yet.

What is a placebo?

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

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

No, you won't know this during the study. This is called 'blinding' and helps ensure that the results are not affected by expectations.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care. Your decision will be fully respected.