NCT07712393RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 17 Jul 2026
- Primary completion date
- 13 Apr 2027
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Asthma
- NCT number
- NCT07712393
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 17 Jul 2026 to the primary completion date, 13 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Lab values
- 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).
Other
- 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.
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.