Study to Evaluate CAY001 in Healthy Volunteers
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
| Condition(s) | Healthy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 co |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Cayuga Biotech, Inc. |
| Locations | Fair Lawn, New Jersey, United States |
| Start date | 2025-12-02 |
| NCT ID | NCT06845839 |
| Official listing | https://clinicaltrials.gov/study/NCT06845839 |