Study to Evaluate CAY001 in Healthy Volunteers

Part of paid clinical trials in Fair Lawn, New Jersey.

Sponsor
Cayuga Biotech, Inc.
Study ID
NCT06845839
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • CAY001 — DRUG
    Polyphosphate (PolyP) - silica nanoparticle (SNP) complex
  • Placebo — OTHER
    Vehicle - aqueous solution

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
May 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CAY001
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence and severity of serious adverse events from Baseline through Day 28. [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
TKL ResearchFair LawnNew Jersey07410
Iris Moscoso, CCRC
[email protected]
201-587-0500
Cary Chiang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
TKL Research· Fair Lawn, NJ

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