Status:
RECRUITING
A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults
Lead Sponsor:
Sinotau Pharmaceutical Group
Conditions:
Prostate Cancer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
June 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07149831
Start Date
June 7 2025
End Date
December 31 2025
Last Update
September 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100089