Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
89Zr-GSK3128349 · 1 trial · 1 indication
SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. SUV was analyzed for each region of interest (ROI) such as liver, kidney, muscle, spleen, heart, lung, bladder, thymus, and if feasible blood and bone. A maximum of 4 PET scans were conducted in each participant. Mean SUV derived from PET-CT has been presented.
Volume of ROI is the volume specified in organs as measured in PET or CT images. Mean volume of ROI for each organ has been presented.
| Arm | Type | Description |
|---|---|---|
| 89Zr-GSK3128349 | EXPERIMENTAL | Subjects will receive a single dose of 89Zr-GSK3128349 as an intravenous (IV) infusion over 20 minutes to deliver a dose of 1 mg |
| Name | Type | Description |
|---|---|---|
| 89Zr-GSK3128349 1 mg | DRUG | 89Zr-GSK3128349 is a mixture of unlabelled and zirconium-labelled GSK3128349, in the form of solution for IV administration, and is associated with about 15 MBq of radioactivity. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase an...
89Zr-GSK3128349 is a positron emission tomography (PET) imaging agent developed by GSK plc. It is a small molecule radiolabeled with zirconium-89 (89Zr) and is used to investigate the biodistribution and clearance of an albumin binding domain antibody (AlbudAb) known as GSK3128349. It is not a therapeutic drug; it is a diagnostic imaging tool.
89Zr-GSK3128349 is used as a PET imaging tracer to study the biodistribution and clearance of the AlbudAb GSK3128349 in healthy male subjects. Its development is focused on understanding drug-related side effects and adverse reactions. It is not approved for clinical use and remains an investigational imaging agent.
89Zr-GSK3128349 is developed by GSK plc, a global pharmaceutical company listed on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical study evaluating this imaging agent.
89Zr-GSK3128349 is in Phase 1 clinical development. It has been evaluated in a single completed Phase 1 trial. As an investigational imaging agent, it has not been approved by the FDA or any regulatory authority for commercial use.
89Zr-GSK3128349 has been studied in one Phase 1 clinical trial, NCT02829307, titled "A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects." The trial was completed and enrolled 8 healthy male volunteers in the Netherlands.