A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05136391|
Recruitment Status : Completed
First Posted : November 29, 2021
Last Update Posted : December 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease (CAD)||Drug: XTR003||Phase 1|
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 .
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR003 in Healthy Chinese Volunteers|
|Actual Study Start Date :||March 29, 2021|
|Actual Primary Completion Date :||August 27, 2021|
|Actual Study Completion Date :||August 27, 2021|
Administration and investigation of myocardial fatty acid radiotracer
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.
- To evaluate the safety of healthy Chinese adults after a single dose of XTR003 intravenous injection. On Day1 of the study all subjects received a single dose 8.0-10 mCi of XTR003 intravenously. [ Time Frame: 0 to 14 days post injection ]All subjects returned to the hospital on Day 2 and Day 7 after XTR003 injection for safety observation that included: Physical examination, vital signs monitoring, blood troponin-I levels, routine blood test, blood biochemistry test, routine urine test, and 12-lead electrocardiogram. On Day 14 all subjects were telephoned for the final follow-up. All adverse events after enrolment in the study will be documented.
- To investigate the biodistribution of XTR003 [ Time Frame: 0 to 5 hours ]XTR003 biodistribution will be determined by whole body PET imaging acquisition at point time intervals at 0-60, 120, 150, 240, and 270 minutes. Venous blood collection of 10 ml from each subject at set time points at 1.5, 3, 5, 10, 30, 60, and 120 minutes after administration and at 4 and 7 hours for radioactivity measurement. Urine collection will begin immediately after injection up to ~ 7.25 hours for radioactivity measurement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136391
|Beijing Anzhen Hospital|
|Beijing, Beijing, China, 100029|