GSK3862995B for COPD

Recruiting at 19 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

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

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Timeline

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

Treatment Details

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.

Participant Groups

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