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RecruitingNCT07149831Updated Sep 2, 2025

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

A Phase 1 interventional study of Flotufolastat F-18 Injection in Prostate Cancer, sponsored by Sinotau Pharmaceutical Group. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Sinotau Pharmaceutical Group · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sinotau Pharmaceutical Group is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Flotufolastat F-18 Injection

    Single dose 5.47\~6.69mCi mCi intravenous injection of Flotufolastat F-18 Injection

    Drug: Flotufolastat F-18 Injection

Interventions

  • DrugFlotufolastat F-18 Injection

    Single dose intravenous injection of Flotufolastat F-18 Injection . Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.

06

What researchers measure

Primary outcomes

  1. To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID)

    Radioactive accumulation (%ID) in target organs following administration of Flotufolastat F-18 Injection.

    Time frame: Day 1

  2. To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults.

    Standardized uptake value (SUV) in target organs following administration of Flotufolastat F-18 Injection.

    Time frame: Day 1

Secondary outcomes

  1. To assess the radiation dosimetry of Flotufolastat F-18 Injection

    Radiation dose in target organs and whole-body effective dose following administration of Flotufolastat F-18 Injection

    Time frame: Day 1

  2. To evaluate the pharmacokinetic of Flotufolastat F-18 Injection

    Radioactivity concentration (%ID/g) in whole blood, plasma, and urine samples at various time points post Flotufolastat F-18 Injection, and associated time activity curves.

    Time frame: Day 1

  3. Proportions of radioactive parent compound in plasma

    To evaluate the pharmacokinetic of Flotufolastat F-18 Injection

    Time frame: Day 1

  4. To evaluate the safety profile of Flotufolastat F-18 Injection

    Types, severity, incidence, and outcomes of adverse events (AEs) and serious adverse events (SAEs) reported during the study period

    Time frame: Day 2

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing Municipality 100089, China
    • Ruimin Wang, Doctor · Contact · wrm@yeah.net · 010-66938008
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07149831
Lead sponsor
Sinotau Pharmaceutical Group
Responsible party
Sponsor
First posted
Sep 2, 2025
Start date
Jun 7, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 2, 2025

Study contacts

Ruimin Wang, Doctor
Contact
wrm@yeah.net
010-66938008

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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