Safety Study of CZ10 in Healthy Volunteers

Launched by NEXTRAST, INC. · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new contrast agent called CZ10, which is used during CT scans to help doctors see images of the body more clearly. The main goal is to find out if CZ10 is safe for use in healthy adults and to see how well it works. The trial will involve 24 healthy volunteers, who will be divided into three groups. Each group will receive different doses of CZ10, and some will receive a placebo (a substance with no active drug) without knowing which one they got. This helps researchers determine the safety and effectiveness of CZ10.

To participate, volunteers must be between 18 and 85 years old, have good access to veins for the injection, and weigh up to 450 pounds. Those who are pregnant, breastfeeding, have certain health conditions, or allergies to similar medical products cannot join the study. Participants will undergo various health checks, including monitoring their vital signs and symptoms after receiving the treatment. This study is an important step in determining whether CZ10 can be used safely in future studies involving patients with vascular disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures
• • Subject is between the ages of 18 to 85 years old, inclusive
• • Has good venous access as determined by the Investigator at screening
• • Weighs up to 450 lbs
• Exclusion Criteria:
• • Is pregnant (as determined by a urine pregnancy test at the time of consent)
• • Has significant cardiovascular, respiratory, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns;
• • Has evidence of moderate to severe renal insufficiency or renal failure (defined as an estimated glomerular filtration rate \<60 ml/minute)
• • Has an allergy to iodinated or other medical intravenous contrast material
• • Weighs more than 450 pounds
• • Is breastfeeding
• • Is a woman of childbearing age who is not using double protection birth control