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Clinical Trials in the USA / NCT06154837
Active, not recruiting Phase 1

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

NCT06154837 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1
Started
2023-11-27
Last updated
2026-05-29

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

GSK3862995B →Placebo

GSK3862995B: GSK3862995B will be administered.

Placebo: Placebo will be administered.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to 36 weeks
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
  • Part B: Number of Participants with AEs and SAEs — Up to 48 weeks
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
  • Part A: Number of Participants with Clinically significant changes in laboratory values — Up to 28 weeks
    Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
  • Part A: Number of Participants with Clinically Significant Change in vital signs — Up to 28 weeks
    Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
  • Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters — Up to 28 weeks
    Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
  • Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis) — Up to 42 weeks
    Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
  • Part B: Number of Participants with Clinically Significant Change in vital signs — Up to 42 weeks
    Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) up to end of intervention period will be assessed.
  • Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters — Up to 42 weeks
    Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.

Trial sites (32)

FacilityCityRegionStatus
GSK Investigational Site Yuma Arizona
GSK Investigational Site Hialeah Florida
GSK Investigational Site Orange City Florida
GSK Investigational Site Plantation Florida
GSK Investigational Site Columbus Georgia
GSK Investigational Site Shelby North Carolina
GSK Investigational Site Medford Oregon
GSK Investigational Site Philadelphia Pennsylvania
GSK Investigational Site Rock Hill South Carolina
GSK Investigational Site Austin Texas
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 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

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Other trials for the same condition

A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1) Recruiting
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation Recruiting
Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3) Recruiting
Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent Active, not recruiting
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06154837 on ClinicalTrials.gov ↗ ← All trials in the USA