RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants

This early-stage study is looking at a new medicine called GSK3862995B. We want to understand how the body handles two slightly different versions of this medicine, including how it's absorbed and processed. We'll also be carefully checking for any side effects and how well healthy adults tolerate it. The aim is to gather important safety information before the medicine is tested in people with lung conditions. This research helps us learn more about new potential treatments and is a vital step in developing new medicines.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

Start

18 Aug 2026

Estimated completion

07 Sep 2027

Pulmonary Disease, Chronic Obstructive

What is this study about?

This study is a very early step in testing a new medicine, currently known by its research code, GSK3862995B. It's called a 'Phase 1' study, which means we're mainly focused on understanding how the medicine works in the body and checking its safety, rather than treating a specific illness. Think of it like a first test drive for a new car – we're seeing how it handles and if it's safe to be on the road.

The main goal is to compare two slightly different ways the medicine is made (we call these 'formulations'). We want to find out how each version is absorbed, moved around, and cleared from the body. This information is really important because it helps scientists decide the best way to give the medicine in the future. We'll also be closely watching for any side effects and how well people tolerate the medicine, which means how comfortable they are taking it.

While this medicine is being developed for a long-term lung condition called Chronic Obstructive Pulmonary Disease (COPD), this particular study is being done in healthy volunteers. This helps us understand the basic effects of the medicine without other health conditions making it more complicated. It's a crucial step in developing new treatments for people who might eventually benefit from this medicine.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine for a lung condition.
It's being done in healthy adults aged 18 to 55 to check safety and how the body handles the medicine.
You won't get direct health benefits, but you'll help advance medical research.
Regular clinic visits, medical checks, and blood tests will be part of taking part.
Potential risks include side effects, which will be monitored closely.
You can stop participating at any time without giving a reason.

Who may be eligible?

To join this study, you need to be a generally healthy adult between 18 and 55 years old. Doctors will check your health with examinations, blood tests, and heart monitoring. You also need to weigh at least 50 kg if you're a man or 45 kg if you're a woman, and your Body Mass Index (BMI) should be between 18 and 32.

There are also some reasons why you might not be able to join. For example, if you have ongoing health problems that aren't well controlled, or if you've had certain infections recently like shingles or serious stomach bugs. If you have a history of cancer within the last 5-10 years (depending on the type), serious allergies to certain medicines, or specific blood test results that are out of the normal range, you wouldn't be able to take part. High blood pressure or allergies to skin creams could also mean you're not suitable.

For women, you can only take part if you are unable to have children, for example, if you have had a hysterectomy or are past menopause. Men can also take part. The study team will discuss all these points with you in detail to make sure it's safe for you to participate.

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 55 years old?
Are you generally healthy, without ongoing serious medical conditions?
Do you weigh at least 50 kg (men) or 45 kg (women) and have a healthy BMI?
Have you *not* had certain serious infections or cancers recently?
Do you *not* have specific serious allergies to medicines or skin conditions?
For women, are you unable to have children (e.g., past menopause or had a hysterectomy)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you're suitable. This would involve medical checks, blood tests, and other assessments. If you qualify, you would receive one of two versions of the new medicine, GSK3862995B.

The study would involve several visits to the clinic, and you might need to stay overnight for some parts. During these visits, the study team would regularly check your health, take blood and urine samples, and ask about any side effects you might be experiencing. These checks help us understand how your body is reacting to the medicine.

They will closely monitor your vital signs, like your heart rate and blood pressure. The total time you'd be involved in the study, from your first visit to your last follow-up, would be explained to you in detail.

Potential risks and benefits

Taking part in a clinical study means you could be helping to develop new medicines that might benefit others in the future, especially those with lung conditions. However, it's important to remember that this medicine is new, so there are no direct health benefits to you personally at this early stage. There's always a chance of experiencing side effects, which could be mild or, in rare cases, more serious. The study team will explain all known potential risks to you and monitor your health very closely throughout the study. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

GSK Investigational Site
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is GSK3862995B?

It's the research code name for a new medicine being developed. It doesn't have a brand name yet.

Why are you studying this medicine in healthy people if it's for a lung condition?

Testing in healthy people first helps us understand how the medicine works in the body and its basic safety, without other health conditions making things more complicated.

What is a 'Phase 1' study?

It's the first stage of human testing for a new medicine. The main goals are to check how safe it is and how the body handles it.

Will I get paid for taking part?

The study information should explain if you will be reimbursed for your time and travel, as this is common in early-stage trials.

What happens after this study?

If this study shows the medicine is safe and gives useful information, it might move to later stages of testing in people with the lung condition.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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