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BAY1075553 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY1075553 | DRUG | Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1 |
Inclusion Criteria: * Part 1: Healthy volunteers only \-- Males ≥ 40 years of age * Part 2: Prostate cancer patients * Males ≥ 18 years of age * Serum PSA (Prostate-Specific Antigen) value above normal. * Patients had an MRI and/or a positive \[11C\] - or \[18F\] -choline PET/CT for prima...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hologic, Inc. | HOLX | 1 | N/A | Undisclosed |
| Intelligent Bio Solutions Inc. | INBS | 1 | - | Undisclosed |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
| GE Healthcare Technologies Inc. | GEHC | 2 | N/A | Undisclosed |
BAY1075553 is an investigational small molecule being studied for diagnostic imaging. It was evaluated in a Phase 1 clinical trial for its safety, tolerability, and diagnostic performance in patients with prostate cancer and healthy volunteers using PET/CT imaging.
BAY1075553 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker LNTH. The company is conducting clinical research on this investigational diagnostic imaging agent.
BAY1075553 is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
BAY1075553 has one completed Phase 1 clinical trial registered as NCT01287845. The study evaluated PET/CT imaging for safety, tolerability, and diagnostic performance of BAY1075553 in patients with prostate cancer and healthy volunteers. The trial enrolled 14 male participants aged 18 years and older.
BAY1075553 is the primary name used in clinical research for this investigational diagnostic imaging agent. No alternative names have been reported in the available clinical trial information.