drugset / Trial / NCT07149831

A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults

NCT07149831

Phase 1 Recruiting 6 enrolled Sinotau Pharmaceutical Group
NaSingle-groupOpen-labelDiagnostic

Summary

Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of Flotufolastat F-18 Injection in 6 healthy elderly Chinese volunteers.

Timeline

Start
2025-06-07
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject FLOTUFOLASTAT Diagnostic / imaging agent 5.47 unknown Intravenous
Subject FLOTUFOLASTAT Diagnostic / imaging agent 6.69 unknown Intravenous

Indications