Clinical trial NCT05195879: A Study of XTR004 Radiotracer in Healthy Volunteers
Official title: A Phase I Study to Evaluate Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR004 in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease (CAD)
Myocardial Ischemia
Keywords: coronary artery disease
positron emission tomography
myocardial perfusion imaging
XTR004
Lead sponsor: Sinotau Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DIAGNOSTIC

Brief summary: XTR004 is a 18F-labeled myocardial perfusion positron emission tomography tracer use to measure myocardial perfusion and myocardial blood flow. XTR004 binds to the myocytes and targets respiratory chain complex 1 in the mitochondria.This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR004 in 10 healthy Chinese adults volunteers.

Detailed description: XTR004 is a 18F-labeled myocardial perfusion PET tracer, the first one developed in China by Sinotau Pharmaceutical Group. XTR004 targets and binds to the mitochondrial complex I protein. XTR004 reflects myocardial function at a molecular level. In pre-clinical studies XTR004 demonstrated high myocardial first-pass extraction and prolonged retention, allowing for early or delayed imaging. XTR004 can be clinically used to measure myocardial perfusion and myocardial blood flow. This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 10 healthy Chinese adults who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 6-8 mCi of XTR004 via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Chinese men and women are included age between 18-40 years
2. Normal vital signs and physical examination
3. No clinical abnormalities in ECG, EEG, and echocardiogram
4. No past history of cardiovascular, cerebrovascular, or gastrointestinal diseases
5. Normal or no clinical significance abnormalities in laboratory tests
6. No any other major or chronic illness
7. No presence of drug use
8. Females adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
9. Voluntarily agree and signed written consent

Exclusion Criteria:

1. Previous history of cardiovascular diseases
2. A history of or physical or radiographic manifestations of any previous brain disease
3. Any previous major disease or unstable condition
4. Subjects who cannot complete XTR004 imaging as required
5. Positive HIV, hepatitis C or Treponema pallidum antibody and hepatitis B surface antigen detection
6. A history of coagulation or coagulation disorder
7. A history of liver or gastrointestinal disease or other conditions that interfere with drug absorption, distribution, excretion or metabolism as determined by the investigator
8. Previous history of cancer
9. High risk of drug allergic reaction
10. A history of alcohol or drug abuse/dependence
11. Exposure to significant occupational radiation (e.g \>50 mvs/year) or exposure to radioactive substances for therapeutic or research purposes over the past 10 years
12. Scheduled surgery or other invasive interventions within one week before drug injection
13. Subjects use any drug or treatment that may interfere with the experimental data or cause serious side effects, as determined by the investigator
14. Pregnant or lactating women
15. Admitted to hospital due to illness during screening period Other conditions that investigators consider inappropriate to participate in a trial.

Primary outcomes:
measure: Physical examination of the major organ systems
timeFrame: up to 14 days post injection
measure: 12-lead Electrocardiography
timeFrame: up to 14 days post injection
measure: Monitoring of body temperature
timeFrame: up to 14 days post injection
measure: Monitoring of respiratory rate
timeFrame: up to 14 days post injection
measure: Monitoring of Blood pressure
timeFrame: up to 14 days post injection
measure: Monitoring of pulse rate
timeFrame: up to 14 days post injection
measure: Changes in Laboratory tests
timeFrame: up to 14 days post injection
measure: Incidence of adverse events
timeFrame: up to 14 days post injection
Secondary outcomes:
measure: Biodistribution of XTR004 after a single dose IV injection. PET scan acquisition;
timeFrame: up to 4.5 hours
measure: Plasma and blood radioactivity analysis
timeFrame: up to 7 hours
measure: Urine radioactivity analysis
timeFrame: up to 7.25 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: