Active not recruitingPHASE1INTERVENTIONAL

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD

This study is investigating a new potential medicine, GB-0895, for adults living with either mild to moderate asthma or Chronic Obstructive Pulmonary Disease (COPD). It's a 'Phase 1' study, which means it's one of the first times this medicine is being tested in people. The main goals are to check if the medicine is safe, how well the body can cope with it, and what happens to the medicine once it's in the body. Researchers will also look for early signs of how GB-0895 might affect these conditions. This kind of research is crucial for developing new treatments to help people breathe better in the future.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Generate Biomedicines

Enrolment target

156

Start

12 Dec 2023

Estimated completion

01 May 2027

Asthma COPD (Chronic Obstructive Pulmonary Disease)

What is this study about?

Imagine you have asthma or COPD, conditions that make breathing difficult. Researchers are always looking for new and better ways to help people manage these conditions. This study is an important early step in testing a new investigational medication called GB-0895. When we say 'investigational,' it means it's not yet available as a medicine you can get from your doctor, as it's still being carefully studied.

The main purpose of this study is to gather basic but vital information. We want to understand if GB-0895 is safe for people to take and how well their bodies tolerate it. We also look at how the body processes the medication – for example, how it's absorbed, distributed, and eventually leaves the body. Finally, we'll be looking for early signs of how the medication might affect the body, which could give us clues about its potential to help with asthma or COPD symptoms.

This is a 'Phase 1' study, which is the very first stage of testing a new medicine in people. These studies usually involve a small group of volunteers and are designed purely to check safety and how the medicine behaves in the body, rather than to prove it can cure a disease or is better than existing treatments. The findings from this study will help decide if GB-0895 is promising enough to move on to larger studies in the future.

Key takeaways

This study is testing a new drug, GB-0895, for asthma and COPD.
It's a 'Phase 1' study, focusing on safety and how the body uses the drug.
You might receive the new active drug or a dummy medication (placebo).
Participation involves injections under the skin and regular clinic visits.
Specific age ranges and health conditions are required for eligibility.
You can stop participating at any time if you change your mind.

Who may be eligible?

The study is open to both men and women. If you have asthma, you need to be an adult between 18 and 65 years old. If you have COPD, you need to be an adult between 40 and 80 years old. For both conditions, you must have had your diagnosis for at least a year and your condition should be classified as mild to moderate.

There are also some health checks to make sure you're suitable. Your blood test results need to be within a healthy range, and you can't have any other serious health problems. It's important that you're not currently pregnant or breastfeeding.

If you have asthma, you shouldn't be a current smoker, or have a significant history of smoking. If you have COPD, you must be a current or past smoker. For both groups, you can't have had a serious flare-up of your breathing condition recently. If you use extra oxygen for your COPD (except for a CPAP machine for sleep apnoea), you wouldn't be able to join this study.

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 years old (for asthma) or 40 and 80 (for COPD)?
Do you have mild to moderate asthma or COPD diagnosed at least a year ago?
Are you able to give your clear agreement to take part in writing?
Do you have no other serious health problems?
Are you not pregnant or breastfeeding?
If you have asthma, are you a non-smoker or have a very limited smoking history?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to check if you're suitable based on the study's requirements. This involves health checks, a review of your medical history, and blood tests. If you qualify, you'd be given the study medication, GB-0895, or a dummy medicine (placebo) by an injection under your skin (SC stands for subcutaneous, for injection under the skin). Neither you nor the study team would know whether you are receiving the active drug or the placebo.

Throughout the study, you would attend regular visits to the clinic where the medical team would monitor your health carefully. This would involve further blood tests, physical examinations, and possibly breathing tests to see how you're responding and to make sure you're safe. The exact number of visits and the total length of time you'd be involved would be explained in detail before you agree to join.

Potential risks and benefits

Taking part in any clinical study involves potential benefits and potential risks. A possible benefit is that you might receive access to a new medication that could potentially help your condition, though this is not guaranteed, especially in early-stage studies like this. You would also be closely monitored by a medical team. Possible risks could include side effects from the investigational medication, or discomfort from procedures like blood tests or injections. There's also a chance you might receive a placebo, which has no active medicine. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

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

Alcanza
Verified postcode
DeLand, United States
Miami Research Institute of South Florida
Verified postcode
Miami, United States
Omega Research
Verified postcode
Orlando, United States
Nucleus Network
Verified postcode
Saint Paul, United States
Southeastern Research Center
Verified postcode
Winston-Salem, United States
DM Clinical Research
Verified postcode
Tomball, United States
Charite Research Organization GmbH
Verified postcode
Berlin, Germany
IKF Pneumologie
Verified postcode
Frankfurt, Germany
Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)
Verified postcode
Hanover, Germany
Hammersmith Medicines Research
Verified postcode
London, United Kingdom
Queen Anne Street Medical Center
Verified postcode
London, United Kingdom
Medicines Evaluation Unit (MEU)
Verified postcode
Manchester, United Kingdom

Common questions

What is GB-0895?

GB-0895 is a new investigational medication that is being tested for asthma and COPD. It is not yet available to the public.

What does 'Phase 1' mean?

Phase 1 means it's an early-stage study, mainly focused on checking if the new medicine is safe and how the body handles it, rather than how well it treats a condition.

Will I definitely get the new medicine?

No, some participants in the study will receive the new medicine, while others will receive a placebo, which looks like the medicine but contains no active drug. This helps researchers compare effects fairly.

What does 'SC' mean for the medicine?

SC stands for 'subcutaneous', which means the medicine will be given as an injection just under the skin.

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 normal medical care.