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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
Sponsor:
Information provided by (Responsible Party):
Sinotau Pharmaceutical Group

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Drug: XTR003 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XTR003
Administration and investigation of myocardial fatty acid radiotracer
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women aged between 18-40 years
  2. Normal electrocardiogram and echocardiography
  3. Normal vital signs and physical examination
  4. No any major illness
  5. No clinically significant abnormalities in laboratory tests
  6. No clinically significant anomalies in 12-lead ECG
  7. Females of child bearing possibility should adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
  8. Voluntarily signed written consent from all subjects

Exclusion Criteria:

  1. Pregnancy or lactating woman
  2. History of cardiovascular disease
  3. History of any brain disease
  4. History of coagulopathy
  5. History of liver or gastrointestinal diseases or other factors that can interfere with drug absorption, distribution, excretion or metabolism
  6. Past history of cancer
  7. History of drug allergy
  8. History of drug abuse or alcohol dependance
  9. Any medications and treatments that may interfere with the test data or may cause serious side effects
  10. Human immunodeficiency virus (HIV), hepatitis C or syphilis antibody test positive, hepatitis B surface antigen positive
  11. Exposure to significant occupational radiation (e.g >50 mvs/year) or exposure radioactive substances for therapeutic or research purposes over the past 10 years
  12. Use of health products or medications (eg. coenzyme Q10, etc.) that have an effect on myocardial energy metabolism within 1 week
  13. Hospital admission due to illness during the screening period

Information from the National Library of Medicine

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


Locations
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China, Beijing
Beijing Anzhen Hospital
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Sinotau Pharmaceutical Group
Publications:
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Responsible Party: Sinotau Pharmaceutical Group
ClinicalTrials.gov Identifier: NCT05136391    
Other Study ID Numbers: STB-XTR003-101
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinotau Pharmaceutical Group:
coronary artery disease; positron emission tomography (PET)
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases