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Prostate CancerPhase 1NCT07149831

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 study testing Flotufolastat F-18 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Flotufolastat F-18 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
7 Jun 2025to 31 Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have the ability to understand the content of study and voluntarily sign the informed consent form.
  • Healthy male or female, aged 18-60 (included).
  • Body mass index (BMI) between 19 and 26 kg/m² (included).
  • 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.
  • Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant.
  • Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up.
  • 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.

Who cannot join

  • Claustrophobia or inability to tolerate imaging examinations for any other reason.
  • Have a history of epilepsy or seizures, excluding childhood febrile seizures.
  • With chronic diseases, including but not limited to:
  • cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.
  • history of psychiatric disorders or currently significant psychiatric conditions
  • Have a history of asthma or allergies.
Show all 20Show fewer
  • Have a history of malignant tumors.
  • 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.
  • Underwent any surgical procedure within 3 months before administration or planned surgery during the study period.
  • Accomplished the blood donation or significant blood loss (>400 mL) within 3 months before administration or during the screening period.
  • Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling).
  • Known allergy to the active ingredient or any excipients of the investigational product.
  • Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration.
  • 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).
  • Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer).
  • Pregnant or breastfeeding women.
  • Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator.
  • QTc intervalis longer than 450 milliseconds during the screening period.
  • 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.
  • Any reason determined by the investigator that could not complet the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruimin Wang, Doctor contact

010-66938008

wrm@yeah.net

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100089

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

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Conditions
Prostate Cancer
Being tested
Flotufolastat F-18 Injection
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flotufolastat F-18 InjectionDrug

    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.

Study groups in NCT07149831
Study groupRoleWhat they receive
Flotufolastat F-18 InjectionExperimentalSingle dose 5.47~6.69mCi mCi intravenous injection of Flotufolastat F-18 Injection
Receives: Drug: Flotufolastat F-18 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Day 1

Secondary outcomes (4)

  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

    Measured: 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.

    Measured: Day 1

  3. Proportions of radioactive parent compound in plasma

    To evaluate the pharmacokinetic of Flotufolastat F-18 Injection

    Measured: 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

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start7 Jun 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07149831
Sponsor's protocol ID
XTR020-101
Status last verified
Aug 2025
First submitted
4 Aug 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flotufolastat F-18 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruimin Wang, Doctor (010-66938008, wrm@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07149831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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