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

RECRUITINGPHASE1

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

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

NCT07149831•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.

Detailed Description

Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). It is intended for the detection of prostate cancer (PCa) lesions.This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 6 healthy Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 5.47\~6.69mCi of Flotufolastat F-18 Injection via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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 (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant.
•5. Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant.
•6. Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up.
•7. Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed.

Exclusion Criteria

•1. Claustrophobia or inability to tolerate imaging examinations for any other reason.
•2. Have a history of epilepsy or seizures, excluding childhood febrile seizures.
•3. With chronic diseases, including but not limited to:
•1. cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.
•2. history of psychiatric disorders or currently significant psychiatric conditions
•4. Have a history of asthma or allergies.
•5. Have a history of malignant tumors.
•6. Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant.
•7. Underwent any surgical procedure within 3 months before administration or planned surgery during the study period.
•8. Accomplished the blood donation or significant blood loss (\>400 mL) within 3 months before administration or during the screening period.
+10 more criteria

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 7, 2025

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

September 2, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Flotufolastat F-18 Injection

DRUG

Contacts

Ruimin Wang, Doctor

CONTACT

010-66938008 wrm@yeah.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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