Flotufolastat F-18 PET imaging to map PSMA distribution 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

This phase 1 test gives Flotufolastat F-18 PET tracer to healthy Chinese adults to check safety, where it goes in the body, radiation dose, and how the body clears it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Sinotau Pharmaceutical Group (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07149831 on ClinicalTrials.gov

What this trial studies

This open-label, nonrandomized, single-center Phase I study enrolled six healthy Chinese volunteers to receive a single intravenous dose (5.47–6.69 mCi) of Flotufolastat F-18. Participants underwent PET imaging and serial blood sampling to measure biodistribution, radiation dosimetry, and pharmacokinetics. Safety and tolerability were monitored with vital signs, ECG, lab tests, and clinical exams before and after injection. The goal was to characterize organ uptake, estimate radiation dose, and document any adverse events in this population.

Who should consider this trial

Good fit: Healthy Chinese adults aged 18–60 with BMI 19–26 kg/m², normal clinical exams and laboratory tests, ability to consent, and willingness to use effective contraception are the intended participants.

Not a fit: People with active prostate cancer, significant medical comorbidities, abnormal screening labs or imaging, pregnant or breastfeeding women, or those outside the specified age/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this tracer could provide clearer, more specific PET images of PSMA-expressing prostate cancer lesions to help with detection and staging.

How similar studies have performed: Other PSMA-targeting PET tracers (for example 68Ga-PSMA-11 and 18F-DCFPyL) have shown strong clinical performance, so the general approach is established though this specific tracer is early-phase.

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 (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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ruimin Wang, Doctor

Conditions Prostate Cancer