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New COPD drug candidate enters early human safety testing

NCT ID NCT06154837

Symptom relief Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called GSK3862995B to see if it is safe and tolerable. First, healthy adults receive a single dose, then people with chronic obstructive pulmonary disease (COPD) receive multiple doses. The goal is to check for side effects and how the drug behaves in the body, not yet to prove it works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

127 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Healthy participants (Part A) * Participant must be 18 to 65 years of age inclusive. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Body weight within the range 50-110 kilogram (kg) (inclusive) * Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m\^2) * Male and/or female of non-childbearing potential Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B) * Participant must be 40 to 75 years of age inclusive. * Body weight within the range 50-110 kg (inclusive) * BMI within the range 19.5-32 kg/m\^2 * Participant has a confirmed diagnosis of COPD for greater than (\>)12 months * Participants must present with a measured post-salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (\<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (\>=) 40% of predicted normal values. * Participants must have a well-documented requirement for optimized standard of care background therapy that includes daily inhaled medication. * A peripheral blood eosinophil count of \>=150 cells/microliter (mcL) at screening * Former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted * Male and/or female of non-childbearing potential. Exclusion Criteria: * Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints. * A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles). * Significant allergies to humanized monoclonal antibodies. * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years * Alanine transaminase (ALT) \>1x upper limit of normal (ULN) * Total bilirubin \>1.5xULN (isolated total bilirubin \>1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (\<) 35%). * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A clinically significant abnormality in 12-lead ECG readings performed at screening * A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary disease, chronic obstructive

Contacts and locations

Locations

  • GSK Investigational Site

    Yuma, Arizona, 85365, United States

  • GSK Investigational Site

    Hialeah, Florida, 33016, United States

  • GSK Investigational Site

    Orange City, Florida, 32763, United States

  • GSK Investigational Site

    Plantation, Florida, 33324, United States

  • GSK Investigational Site

    Columbus, Georgia, 31904, United States

  • GSK Investigational Site

    Shelby, North Carolina, 28150, United States

  • GSK Investigational Site

    Medford, Oregon, 97504, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732, United States

  • GSK Investigational Site

    Austin, Texas, 78744, United States

  • GSK Investigational Site

    Ahrensburg, 22926, Germany

  • GSK Investigational Site

    Berlin, 10117, Germany

  • GSK Investigational Site

    Berlin, 10119, Germany

  • GSK Investigational Site

    Berlin, 14050, Germany

  • GSK Investigational Site

    Dresden, 01069, Germany

  • GSK Investigational Site

    Frankfurt, 60596, Germany

  • GSK Investigational Site

    Hamburg, 20253, Germany

  • GSK Investigational Site

    Hamburg, Hamburg, Germany

  • GSK Investigational Site

    Hanover, 30159, Germany

  • GSK Investigational Site

    Immenhausen, 34376, Germany

  • GSK Investigational Site

    Leipzig, 04207, Germany

  • GSK Investigational Site

    Lübeck, 23552, Germany

  • GSK Investigational Site

    Mainz, 55128, Germany

  • GSK Investigational Site

    Schwerin, 19055, Germany

  • GSK Investigational Site

    Barnsley, S75 3DL, United Kingdom

  • GSK Investigational Site

    Blackpool, FY2 0JH, United Kingdom

  • GSK Investigational Site

    Cambridge, CB2 0GG, United Kingdom

  • GSK Investigational Site

    Cannock, WS11 0BN, United Kingdom

  • GSK Investigational Site

    London, HA1 3UJ, United Kingdom

  • GSK Investigational Site

    London, United Kingdom

  • GSK Investigational Site

    Manchester, M23 9QZ, United Kingdom

  • GSK Investigational Site

    West Yorkshire, LS10 1DU, United Kingdom

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