A Study of GSK4527363
Phase 1
142
about 3.4 years
18–65
6 sites in AZ, CO, NV +3
What this study is about
This trial is testing a treatment called GSK4527363 in healthy people, people with lupus, and healthy Chinese/Japanese people. The goal is to see if it's safe and how well it works.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Belimumab
- 2.Take GSK4527363
- 3.Take Placebo matching GSK4527363
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
belimumab
injection (Injection)
Primary: Parts A, B, C and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Secondary: Part B and D: Area Under the Concentration-time Curve over the First Dosing Interval Between Week (wk) 0 and Week 12 (AUC[0-wk12]) of GSK4527363, Part B and D: Maximum Plasma Concentration Over the First Dosing Interval Between Week 0 and Week 12 (Cmax [0-wk12]) of GSK4527363, Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363, Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363, Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363, Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363, Parts A, B and C: Percentage change from Baseline in cytokine levels
Immune