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

Recruiting Phase 1 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
6 (estimated)
Sponsor
Sinotau Pharmaceutical Group · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Have the ability to understand the content of study and voluntarily sign the informed consent form. 2. Healthy male or female, aged 18-60 (included). 3. Body mass index (BMI) between 19 and 26 kg/m² (included). 4. Vital signs, physical examination, 12-lead electrocardiogram (…
Contacts

Ruimin Wang, Doctor

010-66938008

wrm@yeah.net

CONTACT