A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults
Launched by SINOTAU PHARMACEUTICAL GROUP ·
Trial Information
Current as of September 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new imaging agent called Flotufolastat F-18 Injection, which helps doctors take detailed pictures of the prostate using a special type of scan called a PET scan. The goal is to see if this agent is safe and how it behaves in the body, especially in healthy older adults. This study is important because it may improve how prostate cancer is detected in the future.
The trial is looking for healthy adults, including both men and women, aged between 65 and 74 years old. If you join, you can expect to receive the Flotufolastat F-18 Injection and then undergo scans to track where the agent goes in your body and how much radiation you receive. The study will also monitor your health closely to make sure the injection is safe and well-tolerated. This is an early-phase trial, so it’s focused mainly on safety and how the agent moves through the body rather than treating disease.
Gender
ALL
Eligibility criteria
About Sinotau Pharmaceutical Group
Sinotau Pharmaceutical Group is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for serious health conditions. With a strong focus on advancing healthcare through cutting-edge science, Sinotau specializes in areas such as oncology, autoimmune diseases, and central nervous system disorders. The company prides itself on its commitment to clinical excellence and patient-centric solutions, leveraging a robust pipeline of novel compounds to address unmet medical needs globally. Through strategic partnerships and a dedication to quality, Sinotau aims to enhance patient outcomes and contribute to the advancement of global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported