A Phase I Study to Evaluate XTR003 in Chinese Healthy Volunteers

• Status: Completed
• Trial end date: 2021-08-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sinotau Pharmaceutical Group

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