A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283

GlaxoSmithKline (GSK)

Status and phase

Enrolling

Phase 1

Conditions

Asthma

Treatments

Drug: GSK5784283

Study type

Interventional

Funder types

Industry

Identifiers

NCT07712393

307918

Details and patient eligibility

About

The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
Body weight greater than or equal (>=) 50 kilogram (kg) (110 pounds [lbs]) and body mass index within the range 19 to 30 kilogram per meter square (kg/m^2) (inclusive).
A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion criteria

Hypersensitivity- Participants with allergy/intolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously
History or presence of any clinically significant medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.
Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.
Current smokers (tobacco and/or marijuana) or former smokers with a smoking history >10 pack-years and participants using vaping products, including electronic cigarettes.
Regular alcohol consumption that exceeds the limits specified in the protocol
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read >450 millisecond (msec).