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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 60 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

6 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
9. Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling).
10. Known allergy to the active ingredient or any excipients of the investigational product.
11. Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration.
12. Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer).
13. Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer).
14. Pregnant or breastfeeding women.
15. Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator.
16. QTc intervalis longer than 450 milliseconds during the screening period.
17. Major occupational exposure to ionizing radiation in the past 10 years (e.g., more than 50 mSv/year) or exposure to radioactive materials or ionizing radiation for therapeutic or research purposes.
18. Any reason determined by the investigator that could not complet the study.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Sinotau Pharmaceutical Group

Study start

Jun 7, 2025 Actual

Primary completion

Aug 3, 2025 Actual

Study completion

Aug 3, 2025 Actual

First posted

Sep 2, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.