Actively Recruiting
A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults
Led by Sinotau Pharmaceutical Group · Updated on 2025-09-02
6
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and voluntarily sign informed consent
- Healthy males or females aged 18 to 60 years
- Body mass index (BMI) between 19 and 26 kg/m²
- Normal vital signs, physical exam, ECG, chest X-ray, and abdominal ultrasound or clinically insignificant abnormalities
- Normal or clinically insignificant laboratory test results
- Ability to communicate well and follow study requirements
- Females must use effective contraception during the study and for 6 months after; males must agree to use contraception during the same period
You will not qualify if you...
- Claustrophobia or inability to tolerate imaging exams
- History of epilepsy or seizures (excluding childhood febrile seizures)
- Chronic diseases including cardiovascular, respiratory, gastrointestinal, urinary, hematological, neurological, endocrine, metabolic, musculoskeletal diseases, or psychiatric disorders
- History of asthma or allergies
- History of malignant tumors
- Conditions interfering with drug absorption or metabolism or affecting study results
- Surgery within 3 months before or planned during study
- Blood donation or significant blood loss (>400 mL) within 3 months
- Insufficient venous access for drug administration and sampling
- Known allergy to study drug or excipients
- Use of any medications within 14 days before administration
- Participation in another new drug trial within 4 weeks or 5 half-lives of another drug
- Radiopharmaceutical imaging or treatment within 7 days or 5 half-lives
- Pregnancy or breastfeeding
- Clinically significant abnormal serological results
- QTc interval longer than 450 milliseconds
- Major occupational ionizing radiation exposure in past 10 years
- Any other reason preventing study completion as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100089
Actively Recruiting
Research Team
R
Ruimin Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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