A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmona⦠(NCT06154837) | Clinical Trial Compass
RecruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
United States130 participantsStarted 2023-11-27
Plain-language 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).
Who can participate
Age range18 Years ā 75 Years
SexALL
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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 ā¦
What they're measuring
1
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 36 weeks
2
Part B: Number of Participants with AEs and SAEs
Timeframe: Up to 48 weeks
3
Part A: Number of Participants with Clinically significant changes in laboratory values
Timeframe: Up to 28 weeks
4
Part A: Number of Participants with Clinically Significant Change in vital signs
Timeframe: Up to 28 weeks
5
Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Timeframe: Up to 28 weeks
6
Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis)
Timeframe: Up to 42 weeks
7
Part B: Number of Participants with Clinically Significant Change in vital signs