A Phase I Study to Evaluate XTR003 in Chinese Healthy Volunteers
Status:
Completed
Trial end date:
2021-08-27
Target enrollment:
Participant gender:
Summary
18F-FDG PET imaging is now considered the most effective method used in the clinical
evaluation of viable myocardium. However, the need for fasting or glucose and insulin loading
in the 18F-FDG PET protocol makes it unfavorable for a certain group of patients (i.e.,
insulin-resistance and diabetic patients). XTR003 is a fatty acid analog used for PET
imaging, developed at the Beijing Anzhen Hospital affiliated to Sinotau Pharmaceutical Group.
XTR003 is a promising fatty acid analog and perhaps have a potential clinical utility in the
evaluation of viable myocardium. This phase I study investigated the safety, biodistribution,
radiation dosimetry and Pharmacokinetics of XTR003 in 10 Chinese normal healthy volunteers
both male and female between the ages of 18-40.