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

NCT07712393 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 307918
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Asthma; GSK5784283; Pharmacokinetics; Safety; Tolerability; Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples

  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

  Pre-dose and up to 253 days post dose

Secondary Outcomes (3)

• Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI)

  Up to 253 days

• Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values

  Baseline and up to 253 days

• Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283

  Up to 253 days

Study Arms (2)

GSK5784283 Test Formulation

EXPERIMENTAL

Drug: GSK5784283

GSK5784283 Reference Formulation

EXPERIMENTAL

Drug: GSK5784283

Interventions

GSK5784283 DRUG

GSK5784283 will be administered.

GSK5784283 Reference Formulation; GSK5784283 Test Formulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): April 26, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)