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A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

Primary Purpose

Coronary Artery Disease (CAD)

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

XTR003

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring coronary artery disease; positron emission tomography (PET)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Beijing Anzhen Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XTR003

Arm Description

Administration and investigation of myocardial fatty acid radiotracer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To investigate the biodistribution of XTR003

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.

Full Information

NCT ID

NCT05136391

First Posted

November 23, 2021

Last Updated

November 30, 2021

Sponsor

Sinotau Pharmaceutical Group

1. Study Identification

Unique Protocol Identification Number

NCT05136391

Brief Title

A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

Official Title

A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR003 in Healthy Chinese Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

March 29, 2021 (Actual)

Primary Completion Date

August 27, 2021 (Actual)

Study Completion Date

August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinotau Pharmaceutical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease (CAD)

Keywords

coronary artery disease; positron emission tomography (PET)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XTR003

Arm Type

Experimental

Arm Description

Administration and investigation of myocardial fatty acid radiotracer

Intervention Type

Drug

Intervention Name(s)

XTR003

Intervention Description

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 Measure Information:

Title

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.

Description

Time Frame

0 to 14 days post injection

Secondary Outcome Measure Information:

Title

To investigate the biodistribution of XTR003

Description

Time Frame

0 to 5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

15695790

Citation

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.

Results Reference

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A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers

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