Back to resultsA Study of XTR004 Radiotracer in Healthy Volunteers
Primary Purpose
Coronary Artery Disease (CAD), Myocardial Ischemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
XTR004
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring coronary artery disease, positron emission tomography, myocardial perfusion imaging, XTR004
Eligibility Criteria
Inclusion Criteria:
- Chinese men and women are included age between 18-40 years
- Normal vital signs and physical examination
- No clinical abnormalities in ECG, EEG, and echocardiogram
- No past history of cardiovascular, cerebrovascular, or gastrointestinal diseases
- Normal or no clinical significance abnormalities in laboratory tests
- No any other major or chronic illness
- No presence of drug use
- Females adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
- Voluntarily agree and signed written consent
Exclusion Criteria:
- Previous history of cardiovascular diseases
- A history of or physical or radiographic manifestations of any previous brain disease
- Any previous major disease or unstable condition
- Subjects who cannot complete XTR004 imaging as required
- Positive HIV, hepatitis C or Treponema pallidum antibody and hepatitis B surface antigen detection
- A history of coagulation or coagulation disorder
- A history of liver or gastrointestinal disease or other conditions that interfere with drug absorption, distribution, excretion or metabolism as determined by the investigator
- Previous history of cancer
- High risk of drug allergic reaction
- A history of alcohol or drug abuse/dependence
- 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
- Scheduled surgery or other invasive interventions within one week before drug injection
- Subjects use any drug or treatment that may interfere with the experimental data or cause serious side effects, as determined by the investigator
- Pregnant or lactating women
- Admitted to hospital due to illness during screening period Other conditions that investigators consider inappropriate to participate in a trial.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XTR004
Arm Description
Single dose 6.0-8.0 mCi intravenous injection of XTR004 and investigation of XTR004 (MPI radiotracer).
Outcomes
Primary Outcome Measures
Physical examination of the major organ systems
Safety observation: Observation of Cardiovascular system (blood pressure, pulse rate, and rhythm), Lungs (respiratory rate, chest expansion, and lung auscultation), Abdominal system (for any tenderness or organ enlargement), Nervous system ( cognitive testing, motor strength and control, including mental status), Musculoskeletal system, and Skin for any abnormalities, after drug injection. To report number of participants with changes in physical examination compared to baseline physical examination obtained before drug injection.
12-lead Electrocardiography
Safety observation: Observation of ECG electrical activity pattern in the P-wave, PR interval, QRS wave complex, ST segment, and T-wave if associated with any abnormality after drug injection. To observe and report participants with ECG abnormality compared to baseline ECG obtained before drug injection.
Monitoring of body temperature
Safety observation: Vital sign monitoring of body temperature (degrees celsius ) after drug injection. To report changes in body temperature compared to baseline body temperature obtained before drug injection.
Monitoring of respiratory rate
Safety Observation: Vital sign monitoring of respiratory rate (breath per minute) after drug injection. To report changes in respiratory rate compared to baseline respiratory rate obtained before drug injection.
Monitoring of Blood pressure
Safety Observation: Vital sign monitoring of blood pressure (mmHg) after drug injection. To report changes in blood pressure compared to baseline blood pressure obtained before drug injection.
Monitoring of pulse rate
Safety Observation: Vital sign monitoring of pulse rate (beats per minute) after drug injection. To report changes in pulse rate compared to baseline pulse rate obtained before drug injection.
Changes in Laboratory tests
Safety observation: Measurements of routine blood (g/L), routine urine (mg/dL), and blood troponin-I levels (ng/ml) after drug injection. To observe and report changes in routine blood, routine urine, and blood troponin-I levels compared to baseline values obtained before drug injection.
Incidence of adverse events
Safety Observation: Number of participants with adverse events and severe adverse events after drug injection.
Secondary Outcome Measures
Biodistribution of XTR004 after a single dose IV injection. PET scan acquisition;
Whole-body PET scan obtained at the following time points; at 0-60, 120, 150, 240, and 270 minutes, post injection.
Plasma and blood radioactivity analysis
Venous blood collection of 6ml at 1.5, 3, 5, 10, 30, 60, 120, 240 and 420 minutes for plasma and blood radioactivity analysis, post injection
Urine radioactivity analysis
Urine will be collected up to ~ 7.25 hours to assess for radioactivity, post injection.
Full Information
NCT ID
NCT05195879
First Posted
July 22, 2021
Last Updated
January 23, 2022
Sponsor
Sinotau Pharmaceutical Group
1. Study Identification
Unique Protocol Identification Number
NCT05195879
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD), Myocardial Ischemia
Keywords
coronary artery disease, positron emission tomography, myocardial perfusion imaging, XTR004
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XTR004
Arm Type
Experimental
Arm Description
Single dose 6.0-8.0 mCi intravenous injection of XTR004 and investigation of XTR004 (MPI radiotracer).
Intervention Type
Diagnostic Test
Intervention Name(s)
XTR004
Intervention Description
Single dose intravenous injection of XTR004. Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.
Primary Outcome Measure Information:
Title
Physical examination of the major organ systems
Description
Safety observation: Observation of Cardiovascular system (blood pressure, pulse rate, and rhythm), Lungs (respiratory rate, chest expansion, and lung auscultation), Abdominal system (for any tenderness or organ enlargement), Nervous system ( cognitive testing, motor strength and control, including mental status), Musculoskeletal system, and Skin for any abnormalities, after drug injection. To report number of participants with changes in physical examination compared to baseline physical examination obtained before drug injection.
Time Frame
up to 14 days post injection
Title
12-lead Electrocardiography
Description
Safety observation: Observation of ECG electrical activity pattern in the P-wave, PR interval, QRS wave complex, ST segment, and T-wave if associated with any abnormality after drug injection. To observe and report participants with ECG abnormality compared to baseline ECG obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Monitoring of body temperature
Description
Safety observation: Vital sign monitoring of body temperature (degrees celsius ) after drug injection. To report changes in body temperature compared to baseline body temperature obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Monitoring of respiratory rate
Description
Safety Observation: Vital sign monitoring of respiratory rate (breath per minute) after drug injection. To report changes in respiratory rate compared to baseline respiratory rate obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Monitoring of Blood pressure
Description
Safety Observation: Vital sign monitoring of blood pressure (mmHg) after drug injection. To report changes in blood pressure compared to baseline blood pressure obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Monitoring of pulse rate
Description
Safety Observation: Vital sign monitoring of pulse rate (beats per minute) after drug injection. To report changes in pulse rate compared to baseline pulse rate obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Changes in Laboratory tests
Description
Safety observation: Measurements of routine blood (g/L), routine urine (mg/dL), and blood troponin-I levels (ng/ml) after drug injection. To observe and report changes in routine blood, routine urine, and blood troponin-I levels compared to baseline values obtained before drug injection.
Time Frame
up to 14 days post injection
Title
Incidence of adverse events
Description
Safety Observation: Number of participants with adverse events and severe adverse events after drug injection.
Time Frame
up to 14 days post injection
Secondary Outcome Measure Information:
Title
Biodistribution of XTR004 after a single dose IV injection. PET scan acquisition;
Description
Whole-body PET scan obtained at the following time points; at 0-60, 120, 150, 240, and 270 minutes, post injection.
Time Frame
up to 4.5 hours
Title
Plasma and blood radioactivity analysis
Description
Venous blood collection of 6ml at 1.5, 3, 5, 10, 30, 60, 120, 240 and 420 minutes for plasma and blood radioactivity analysis, post injection
Time Frame
up to 7 hours
Title
Urine radioactivity analysis
Description
Urine will be collected up to ~ 7.25 hours to assess for radioactivity, post injection.
Time Frame
up to 7.25 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chinese men and women are included age between 18-40 years
Normal vital signs and physical examination
No clinical abnormalities in ECG, EEG, and echocardiogram
No past history of cardiovascular, cerebrovascular, or gastrointestinal diseases
Normal or no clinical significance abnormalities in laboratory tests
No any other major or chronic illness
No presence of drug use
Females adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
Voluntarily agree and signed written consent
Exclusion Criteria:
Previous history of cardiovascular diseases
A history of or physical or radiographic manifestations of any previous brain disease
Any previous major disease or unstable condition
Subjects who cannot complete XTR004 imaging as required
Positive HIV, hepatitis C or Treponema pallidum antibody and hepatitis B surface antigen detection
A history of coagulation or coagulation disorder
A history of liver or gastrointestinal disease or other conditions that interfere with drug absorption, distribution, excretion or metabolism as determined by the investigator
Previous history of cancer
High risk of drug allergic reaction
A history of alcohol or drug abuse/dependence
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
Scheduled surgery or other invasive interventions within one week before drug injection
Subjects use any drug or treatment that may interfere with the experimental data or cause serious side effects, as determined by the investigator
Pregnant or lactating women
Admitted to hospital due to illness during screening period Other conditions that investigators consider inappropriate to participate in a trial.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of XTR004 Radiotracer in Healthy Volunteers
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