NCT06845839

Study to Evaluate CAY001 in Healthy Volunteers

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cayuga Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CAY001	Polyphosphate (PolyP) - silica nanoparticle (SNP) complex
OTHER	Placebo	Vehicle - aqueous solution

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-02-25
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study