A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered CAY001 in Healthy Volunteer Subjects
Cayuga Biotech, Inc.
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
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
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. * Aspa…
Interventions
- DrugCAY001
Polyphosphate (PolyP) - silica nanoparticle (SNP) complex
- OtherPlacebo
Vehicle - aqueous solution
Location
- TKL ResearchFair Lawn, New Jersey