Actively Recruiting
Phase 1 Randomized Study Comparing Pharmacokinetics of Two GSK5784283 Formulations in Healthy Adults by Injection
Led by GlaxoSmithKline · Updated on 2026-07-29
24
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing how two different forms of the study medicine GSK5784283 are processed in the bodies of healthy adults. This phase 1 study aims to understand the pharmacokinetics of GSK5784283, evaluating its safety, how well it is tolerated, and whether the two formulations behave similarly in the body. Participants will receive one of two versions of GSK5784283 by injection. The study is randomized and parallel in design, meaning participants are assigned to either the test or reference formulation without switching. The research includes monitoring blood levels of the drug over time to assess concentration and exposure. Participants will be involved in regular monitoring up to 253 days after dosing. This includes blood tests to measure drug levels, assessments for side effects or adverse events, laboratory tests, vital signs, and heart monitoring using ECGs. Researchers will also check for immune responses to the drug through antibody testing, ensuring comprehensive safety and effectiveness evaluations during the study period.
CONDITIONS
Brief Title
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults as confirmed by medical evaluation including history, physical exam, lab tests, and ECG
- Body weight at least 50 kg (110 lbs) and BMI between 19 and 30 kg/m²
- Females must be of non-childbearing potential as defined in the protocol
- Able to give signed informed consent and follow study requirements
You will not qualify if you...
- Allergy or intolerance to biologic therapies or ingredients used in subcutaneous products
- Significant medical conditions that affect drug processing or pose study risks
- Abnormal findings in exams or labs that may risk safety or affect study results
- Live vaccines within 1 month before screening or planned during the study
- Biologic treatments within 3 months or 5 half-lives before study dosing
- Current smokers or former smokers with over 10 pack-years history, or users of vaping products
- Excessive alcohol use beyond protocol limits
- Sensitivity to study treatments or components contraindicating participation
- QTc interval over 450 milliseconds on ECG
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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