Last updated: 07/16/2025 18:50:07
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
GSK study ID
221531
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 36 weeks
Part B: Number of Participants with AEs and SAEs
Timeframe: Up to 48 weeks
Part A: Number of Participants with Clinically significant changes in laboratory values
Timeframe: Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in vital signs
Timeframe: Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Timeframe: Up to 28 weeks
Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis)
Timeframe: Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in vital signs
Timeframe: Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Timeframe: Up to 42 weeks
Secondary outcomes:
Part A: Area Under the Concentration-time Curve to the Last Quantifiable Concentration [AUC(0-t)]
Timeframe: Up to 28 weeks
Part A: Area Under the Concentration-time Curve to the Infinity (inf) [AUC(0-inf)]
Timeframe: Up to 28 weeks
Part A: Maximum Concentration (Cmax)
Timeframe: Up to 28 weeks
Part B: Area Under the Concentration-time Curve Over the Dosing Interval [AUC(0-tau)]
Timeframe: Up to 42 weeks
Part B: Cmax
Timeframe: Up to 42 weeks
Part A: Number of Participants with Anti-Drug Antibodies (ADA) against GSK3682995B
Timeframe: Up to 28 weeks
Part B: Number of participants with Incidence of Anti-Drug Antibodies (ADA) against GSK3682995B
Timeframe: Up to 42 weeks
Part A: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Timeframe: Baseline and up to 28 weeks
Part B: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Timeframe: Baseline and up to 42 weeks
Interventions:
Enrollment:
130
Primary completion date:
2027-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2023 to March 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
Yes
- Healthy participants (Part A)
- Participant must be 18 to 65 years of age inclusive.
- 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).
Inclusion and 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).
Trial location(s)
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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