RecruitingPhase 1NCT06154837

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

A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease

Sponsor

GlaxoSmithKline

Enrollment

130 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Pulmonary Disease, Chronic Obstructive

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing the safety and tolerability of a new investigational drug called GSK3862995B. The study is done in two parts: first in healthy volunteers to establish safety, and then in people with moderate-to-severe COPD (chronic obstructive pulmonary disease) to see how the drug behaves in people with the condition and whether it shows early signs of benefit. **You may be eligible if...** - For healthy volunteers: you are 18–65 years old, in good health, and not of childbearing potential - For COPD participants: you are 40–75 years old, have had confirmed COPD for more than 12 months, your lung function tests show airflow obstruction, you require daily inhaled medication, and you have a blood eosinophil count of at least 150 cells/µL - For COPD: you may be a current or former smoker **You may NOT be eligible if...** - You have poorly controlled or serious medical conditions that could affect your safety or the study results - You have a history of recurrent infections or a current chronic infection - You have a significant allergy to monoclonal antibodies or severe drug hypersensitivity - You have had cancer (lymphoma, leukemia, or other malignancy) in the past 5 years, or breast cancer in the past 10 years - You have abnormal liver function tests or a history of liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGSK3862995B

GSK3862995B will be administered.

DRUGPlacebo

Placebo will be administered.

Locations(32)

GSK Investigational Site

Yuma, Arizona, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Shelby, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Ahrensburg, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Dresden, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hanover, Germany

GSK Investigational Site

Immenhausen, Germany

GSK Investigational Site

Leipzig, Germany

GSK Investigational Site

Lübeck, Germany

GSK Investigational Site

Mainz, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Schwerin, Germany

GSK Investigational Site

Barnsley, United Kingdom

GSK Investigational Site

Blackpool, United Kingdom

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Cannock, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Manchester, United Kingdom

GSK Investigational Site

West Yorkshire, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06154837

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