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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease (NCT06154837) is a Phase 1 interventional studying Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pulmonary Disease, Chronic Obstructive, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pulmonary Disease, Chronic Obstructive subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

GSK3862995B

GSK3862995B will be administered.

DRUG

Placebo

Placebo will be administered.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06154837), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06154837 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06154837?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06154837?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06154837. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06154837. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.