drugset / Trial / NCT07101354
Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents
RandomizedFactorialQuadruple-blindOther
Summary
Phase I: Primary Research Objective: Evaluate the safety, tolerability, and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects. Secondary Research Objective: Based on the safety and pharmacokinetic results, assess the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of DGPR1008.
Timeline
- Start
- 2024-06-24
- Primary completion
- 2024-07-29
- Completion
- 2024-09-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DGPR1008 | Diagnostic / imaging agent | 0.01 mg/kg | Intravenous |
| Subject | DGPR1008 | Diagnostic / imaging agent | 0.02 mg/kg | Intravenous |
| Subject | DGPR1008 | Diagnostic / imaging agent | 0.04 mg/kg | Intravenous |
| Subject | DGPR1008 | Diagnostic / imaging agent | 0.08 mg/kg | Intravenous |