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Investigating GSK3862995B in Healthy Individuals and Those with COPD

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

Phase 1 Interventional GlaxoSmithKline · NCT06154837

This study is testing a new drug called GSK3862995B to see how safe it is for both healthy people and those with COPD.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations32 sites (Yuma, Arizona and 31 other locations)
Trial IDNCT06154837 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and tolerability of the drug GSK3862995B in both healthy participants and individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD). It involves administering ascending doses of the drug to assess its effects, with a focus on understanding how it performs in patients with COPD compared to healthy individuals. The study will include both single and repeat doses to gather comprehensive data on the drug's safety profile.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40 to 75 with a confirmed diagnosis of COPD and specific lung function criteria.

Not a fit: Patients with mild or no respiratory conditions or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients suffering from COPD.

How similar studies have performed: Other studies have shown promise in evaluating new treatments for COPD, but the specific approach of GSK3862995B is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Yuma, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Disease, Chronic ObstructiveGSK3862995BChronic Obstructive Pulmonary DiseasePhase 1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.