Recruiting
Phase 1

GSK5784283

Sponsor:

GlaxoSmithKline

Code:

NCT07712393

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

GSK5784283

Study Details

Brief summary:

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.

Conditions

Asthma

Study ID

NCT07712393

Start date

Jul 17, 2026

Status verified date

Jul, 2026

Completion date

Apr 26, 2027

Anticipated

Primary completion date

Apr 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GSK5784283 Test Formulation

experimental: GSK5784283 Reference Formulation

Interventions

GSK5784283

GSK5784283 will be administered.

Primary outcome measure

  • Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples [ Time Frame: Pre-dose and up to 253 days post dose ]
  • Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples [ Time Frame: Pre-dose and up to 253 days post dose ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78744

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sean Gilbey

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Asthma
  • GSK5784283
  • Pharmacokinetics
  • Safety
  • Tolerability
  • Healthy volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-29.