NCT05136391

A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR003 in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

XTR003 is a PET imaging radiopharmaceutical agent used to trace myocardial fatty acid metabolism. XTR003 is a modified fatty acid that enters the myocytes and passes through mitochondrial membrane by the same process as the natural existing fatty acids and then undergoes partial β-oxidation before being trapped in the mitochondria. In preclinical study XTR003 showed high myocardial uptake and retention \[1\]. This is a phase I study, the study will be open-label, nonrandomised, single-arm, single-center clinical study. Subjects will receive single dose of XTR003. Safety, biodistribution, radiation dosimetry and Pharmacokinetics was investigated.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	XTR003	Single dose of 8.0-10 mCi of XTR003 will be injected on the first day of the study (Day 1). Serial whole-body PET imaging will be acquired after dose injection.

Timeline

• Start date: 2021-03-29
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2021-11-29
• Last updated: 2021-12-15

Locations

1 site across 1 country: China