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RecruitingPhase 1

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

Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two forms of GSK5784283 in healthy adults. It looks at how the medicine moves through the body over time, whether the two forms act the same way, and how safe and well tolerated they are.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be healthy based on your health history, exam, lab tests, and an ECG (a test of the heart’s electrical activity).
  • Weigh at least 110 pounds (50 kg) and have a body mass index (BMI) of 19 to 30. BMI compares weight with height.
  • Women must be unable to become pregnant, as defined by the study rules.
  • Be able to sign a consent form and follow the study rules.

Who can't join

  • Have an allergy or intolerance to biologic medicines (medicines made from living sources), ingredients in products injected under the skin, or study medicines. Other allergies may also rule you out.
  • Have a major health condition that changes how your body handles medicines, makes the study unsafe, or affects the results.
  • Have abnormal exam, blood test, urine test, or vital sign results that the study doctor thinks could affect your safety, participation, or study results.
  • Had a live vaccine within 1 month before screening, or plan to get one during the study.
  • Used a biologic medicine within 3 months before study treatment, or within the time it takes for the medicine’s level to drop by half five times, whichever is longer.
  • Currently smoke tobacco or marijuana, use vaping products, or previously smoked more than 10 pack-years. Ten pack-years equals one pack a day for 10 years.
  • Regularly drink more alcohol than the study rules allow.
  • Have a corrected QT interval above 450 milliseconds on an ECG. This measures part of the heart’s electrical cycle.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TX