Status:
COMPLETED
A Study of XTR004 Radiotracer in Healthy Volunteers
Lead Sponsor:
Sinotau Pharmaceutical Group
Conditions:
Coronary Artery Disease (CAD)
Myocardial Ischemia
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
XTR004 is a 18F-labeled myocardial perfusion positron emission tomography tracer use to measure myocardial perfusion and myocardial blood flow. XTR004 binds to the myocytes and targets respiratory cha...
Detailed Description
XTR004 is a 18F-labeled myocardial perfusion PET tracer, the first one developed in China by Sinotau Pharmaceutical Group. XTR004 targets and binds to the mitochondrial complex I protein. XTR004 refle...
Eligibility Criteria
Inclusion
- Chinese men and women are included age between 18-40 years
- Normal vital signs and physical examination
- No clinical abnormalities in ECG, EEG, and echocardiogram
- No past history of cardiovascular, cerebrovascular, or gastrointestinal diseases
- Normal or no clinical significance abnormalities in laboratory tests
- No any other major or chronic illness
- No presence of drug use
- Females adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
- Voluntarily agree and signed written consent
Exclusion
- Previous history of cardiovascular diseases
- A history of or physical or radiographic manifestations of any previous brain disease
- Any previous major disease or unstable condition
- Subjects who cannot complete XTR004 imaging as required
- Positive HIV, hepatitis C or Treponema pallidum antibody and hepatitis B surface antigen detection
- A history of coagulation or coagulation disorder
- A history of liver or gastrointestinal disease or other conditions that interfere with drug absorption, distribution, excretion or metabolism as determined by the investigator
- Previous history of cancer
- High risk of drug allergic reaction
- A history of alcohol or drug abuse/dependence
- Exposure to significant occupational radiation (e.g \>50 mvs/year) or exposure to radioactive substances for therapeutic or research purposes over the past 10 years
- Scheduled surgery or other invasive interventions within one week before drug injection
- Subjects use any drug or treatment that may interfere with the experimental data or cause serious side effects, as determined by the investigator
- Pregnant or lactating women
- Admitted to hospital due to illness during screening period Other conditions that investigators consider inappropriate to participate in a trial.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05195879
Start Date
March 23 2021
End Date
July 30 2021
Last Update
February 7 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000