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

Launched by GLAXOSMITHKLINE · Nov 26, 2023

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ClinConnect Summary

This clinical trial is investigating a new medication called GSK3862995B to see if it is safe for healthy individuals and for people with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to understand how well the medication is tolerated when given in increasing doses. The trial is currently looking for participants aged 18 to 75 who meet certain health criteria. Healthy participants should have no serious health issues, while those with COPD must have had a diagnosis for over a year and must be currently taking prescribed inhaled medication for their condition.

If you choose to participate, you will undergo health evaluations to ensure you meet the study requirements. Participants can expect to receive either a single dose or repeated doses of the medication, and will be monitored closely for any side effects. This trial is important because it aims to gather information that could help develop new treatments for COPD, a condition that affects breathing. If you’re interested and think you might qualify, this could be a valuable opportunity to contribute to medical research.

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Eligibility 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).