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RECRUITING
NCT07149831
PHASE1

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

Sponsor: Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

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.

Official title: An Open-label, Single-center, Single-arm Phase I Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-06-07

Completion Date

2025-12-31

Last Updated

2025-09-02

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Flotufolastat F-18 Injection

Single dose intravenous injection of Flotufolastat F-18 Injection . Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China