MedDataX Logo

A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

NCT ID: NCT05136391

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease (CAD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

coronary artery disease; positron emission tomography (PET)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

XTR003

Administration and investigation of myocardial fatty acid radiotracer

Group Type EXPERIMENTAL

XTR003

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15695790 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39923833 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STB-XTR003-101

Identifier Type: -

Identifier Source: org_study_id