A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

NCT05136391 | Completed Phase 1 DMC

• 1 other identifier: STB-XTR003-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

coronary artery disease; positron emission tomography (PET)

Outcome Measures

Primary Outcomes (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.

  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.

  0 to 14 days post injection

Secondary Outcomes (1)

• To investigate the biodistribution of XTR003

  0 to 5 hours

Study Arms (1)

XTR003

EXPERIMENTAL

Administration and investigation of myocardial fatty acid radiotracer

Drug: XTR003

Interventions

XTR003 DRUG

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.

XTR003

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged between 18-40 years
• Normal electrocardiogram and echocardiography
• Normal vital signs and physical examination
• No any major illness
• No clinically significant abnormalities in laboratory tests
• No clinically significant anomalies in 12-lead ECG
• 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
• Voluntarily signed written consent from all subjects

You may not qualify if:

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

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (2)

• 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.

  PMID: 15695790 BACKGROUND

• 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.

  PMID: 39923833 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: November 29, 2021
• Study Start: March 29, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

CN (1)