Phase 1 Study of Intravenous CAY001 to Assess Safety and Effects in Healthy Adults Aged 18 to 50

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001, a drug given intravenously. This first-in-human, randomized, double-blind, placebo-controlled study involves healthy male and female volunteers aged 18 to 50 years. The goal is to better understand how CAY001 behaves in the body and how safe it is at different dose levels. Participants will be randomly assigned to receive either CAY001 or a placebo. The study will test three different dose levels of CAY001 given as a single ascending dose to groups of subjects. Approximately 24 healthy volunteers will take part in this study. Each participant will be closely monitored during and after dosing to evaluate the effects and how the drug is processed in the body. During the study, researchers will perform physical exams, vital sign checks, electrocardiograms ECGs, blood and urine tests, and other laboratory assessments to track changes from the start of the study through 28 days after dosing. Safety will be carefully monitored by recording any adverse events and changes in various health parameters. Pharmacokinetic measurements will also be taken up to 24 hours after dosing to understand the drugs behavior. Participants will be involved in scheduled visits and assessments throughout the study period to ensure their well-being and to collect necessary data.

Study to Evaluate CAY001 in Healthy Volunteers