Apply to Trial

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

GSK3862995B for COPD

Recruiting at 31 trial locations

Overseen ByEU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must be taking: Inhaled medications

Disqualifiers: Recurrent infections, Cancer, Liver disease, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called GSK3862995B, a potential drug for Chronic Obstructive Pulmonary Disease (COPD). The main goal is to assess the safety and tolerability of this treatment at various doses. Healthy participants will receive a single dose, while those with COPD will receive repeated doses. Individuals with COPD who have had the condition for over a year and rely on daily inhaled medication might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have a requirement for daily inhaled medication as part of their standard care for COPD.

Is there any evidence suggesting that GSK3862995B is likely to be safe for humans?

Research has shown that GSK3862995B is under careful study for its safety in humans. One study involving individuals with bronchiectasis, a long-term lung disease, found that GSK3862995B was generally well-tolerated, with most participants not experiencing serious side effects.

Another study administered different single doses of the treatment to healthy participants to observe their reactions. Although detailed results are not yet available, testing in healthy individuals suggests some confidence in its safety at low doses.

It is important to note that this treatment remains in the early stages of testing. Researchers continue to gather information about its safety. However, no major safety concerns have been reported in these initial studies.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for COPD?

Most treatments for COPD, like bronchodilators and corticosteroids, work by relaxing airway muscles or reducing inflammation. But GSK3862995B works differently, targeting specific pathways involved in COPD progression. Researchers are excited about this treatment because it offers a novel mechanism of action that could potentially address the underlying causes of COPD more effectively. Additionally, unlike traditional treatments that are often inhaled, GSK3862995B is delivered as an oral medication, which could simplify administration and improve patient compliance.

What evidence suggests that GSK3862995B might be an effective treatment for COPD?

Research has shown that GSK3862995B is under investigation as a potential treatment for COPD (Chronic Obstructive Pulmonary Disease) in this trial. In a study involving patients with bronchiectasis, a similar lung condition, the drug improved symptoms. It targets the body's inflammation process, which significantly impacts these lung diseases. Early results suggest that GSK3862995B might reduce inflammation and enhance lung function. However, further research is necessary to confirm its benefits specifically for COPD. Participants in this trial will receive either GSK3862995B or a placebo to evaluate its effectiveness further.¹ ² ⁴ ⁵ ⁶

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This study is for healthy adults and those with Chronic Obstructive Pulmonary Disease (COPD). Healthy participants must be aged 18-65, while those with COPD should be 40-75 years old. All must weigh between 50-110 kg and have a BMI of 19.5-32 kg/m^2. They should not be able to bear children or be pregnant.

Inclusion Criteria

I am generally healthy as confirmed by recent medical exams and tests.

My weight is between 50 and 110 kg.

I have COPD.

See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Healthy participants receive single ascending doses of GSK3862995B or placebo

Up to 28 weeks

Treatment Part B

Participants with COPD receive repeat doses of GSK3862995B or placebo

Up to 42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

GSK3862995B

Trial Overview The trial is testing GSK3862995B's safety and how well people can tolerate it. It involves giving different doses to two groups: one group of healthy individuals will receive a single dose, while another group with COPD will get repeated doses.

How Is the Trial Designed?

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Repeat dose of GSK3862995BExperimental Treatment1 Intervention

Participants with COPD will receive repeat doses of GSK3862995B.

Group II: Part A Dose Level 6: Single dose of GSK3862995BExperimental Treatment1 Intervention