A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

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.

Timeline

Start

2021-03-29

Primary completion

2021-08-27

Completion

2021-08-27

Publications

• Background Shoup TM, Elmaleh DR, Bonab AA, Fischman AJ. Evaluation of trans-9-18F-fluoro-3,4-Methyleneheptadecanoic acid as a PET tracer for myocardial fatty acid imaging. J Nucl Med. 2005 Feb;46(2):297-304.
• Mou T, Meng J, Lin C, Xie X, Hsu B, Zhang X. XTR003, a fatty acid metabolism PET tracer: A phase I study to evaluate the safety, biodistribution, radiation dosimetry, and pharmacokinetics in healthy volunteers. J Nucl Cardiol. 2025 Apr;46:102144. doi: 10.1016/j.nuclcard.2025.102144. Epub 2025 Feb 7.

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Indications