A Study of XTR004 Radiotracer in Healthy Volunteers

NCT05195879 | Completed Phase 1 DMC

• 1 other identifier: STB-XTR004-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD); Myocardial Ischemia

Keywords

coronary artery disease; positron emission tomography; myocardial perfusion imaging; XTR004

Outcome Measures

Primary Outcomes (8)

• 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.

  up to 14 days post 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.

  up to 14 days post 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.

  up to 14 days post 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.

  up to 14 days post 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.

  up to 14 days post 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.

  up to 14 days post 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.

  up to 14 days post injection

• Incidence of adverse events

  Safety Observation: Number of participants with adverse events and severe adverse events after drug injection.

  up to 14 days post injection

Secondary Outcomes (3)

• Biodistribution of XTR004 after a single dose IV injection. PET scan acquisition;

  up to 4.5 hours

• Plasma and blood radioactivity analysis

  up to 7 hours

• Urine radioactivity analysis

  up to 7.25 hours

Study Arms (1)

XTR004

EXPERIMENTAL

Single dose 6.0-8.0 mCi intravenous injection of XTR004 and investigation of XTR004 (MPI radiotracer).

Diagnostic Test: XTR004

Interventions

XTR004 DIAGNOSTIC_TEST

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.

XTR004

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; 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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: January 19, 2022
• Study Start: March 23, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)