Study to Evaluate CAY001 in Healthy Volunteers
This study tests a new drug called CAY001 in healthy volunteers to see how safe it is and how the body processes it. Participants will receive either the study drug or a placebo, and researchers will monitor them closely for any side effects.
Key Objective:This trial aims to establish the safety profile and determine how the body absorbs, distributes, and eliminates CAY001 at different dose levels.
Who to Consider:Healthy adult men and women with no significant medical conditions who are willing to receive an investigational drug and undergo close medical monitoring should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001 when administered to healthy male and female subjects. Three dose levels will be evaluated with a total of approximately 24 subjects.
Eligibility Criteria
Inclusion Criteria: 1. The subject is able to provide written informed consent 2. The subject is male or female (based on gender assigned at birth), 18-50 years of age inclusive 3. The subject has a body mass index ≥ 18 and ≤ 30.0 kg/m2 and weighs at least 61 kg for males and females 4. The subject is in good general health per Investigator evaluation for age as determined by medical history, vital signs, physical examination findings, screening laboratory test results, and 12-lead ECG results. Specific inclusionary laboratory values prior to randomization require the following. * Aspartate transaminase (AST), alanine transaminase (ALT) \< 1.5 x upper limit of normal (ULN) * Total serum bilirubin and alkaline phosphatase levels \< 1.2 x ULN * White blood cell (WBC) count, platelet count, and hemoglobin level within the normal range; out of range values are allowed if per the Investigator they are not deemed clinically significant * PT/INR, partial thromboplastin time (PTT), and D