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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Arizona
GSK Investigational Site
RECRUITING
Yuma
Florida
GSK Investigational Site
RECRUITING
Hialeah
GSK Investigational Site
RECRUITING
Plantation
Georgia
GSK Investigational Site
RECRUITING
Columbus
North Carolina
GSK Investigational Site
RECRUITING
Shelby
GSK Investigational Site
RECRUITING
Wilmington
Oregon
GSK Investigational Site
RECRUITING
Medford
South Carolina
GSK Investigational Site
RECRUITING
Rock Hill
Texas
GSK Investigational Site
RECRUITING
Austin
Other Locations
Germany
GSK Investigational Site
RECRUITING
Ahrensburg
GSK Investigational Site
RECRUITING
Berlin
GSK Investigational Site
RECRUITING
Berlin
GSK Investigational Site
RECRUITING
Berlin
GSK Investigational Site
RECRUITING
Dresden
GSK Investigational Site
RECRUITING
Frankfurt
GSK Investigational Site
RECRUITING
Hamburg
GSK Investigational Site
RECRUITING
Hamburg
GSK Investigational Site
RECRUITING
Hanover
GSK Investigational Site
RECRUITING
Immenhausen
GSK Investigational Site
RECRUITING
Leipzig
GSK Investigational Site
RECRUITING
Lübeck
GSK Investigational Site
RECRUITING
Mainz
GSK Investigational Site
RECRUITING
München
GSK Investigational Site
RECRUITING
Schwerin
United Kingdom
GSK Investigational Site
RECRUITING
Barnsley
GSK Investigational Site
RECRUITING
Blackpool
GSK Investigational Site
RECRUITING
Cambridge
GSK Investigational Site
RECRUITING
Cannock
GSK Investigational Site
RECRUITING
London
GSK Investigational Site
RECRUITING
London
GSK Investigational Site
RECRUITING
Manchester
GSK Investigational Site
RECRUITING
West Yorkshire
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 130
Treatments
Experimental: Part A Dose Level 1: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Experimental: Part A Dose Level 2: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Experimental: Part A Dose Level 3: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Experimental: Part A Dose Level 4: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Experimental: Part A Dose Level 5: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Experimental: Part A Dose Level 6: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Placebo_comparator: Part A: Placebo
Healthy participants will receive single dose of placebo.
Experimental: Part B: Repeat dose of GSK3862995B
Participants with COPD will receive repeat doses of GSK3862995B.
Placebo_comparator: Part B: Placebo
Participants with COPD will receive repeat doses of placebo.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov