Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06845839

Study to Evaluate CAY001 in Healthy Volunteers

Led by Cayuga Biotech, Inc. · Updated on 2026-05-05

24

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study to Evaluate CAY001 in Healthy Volunteers

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent
  • Male or female aged 18 to 50 years
  • Body mass index between 18 and 30 kg/m2
  • Weighs at least 61 kg
  • In good general health based on medical history, physical exam, vital signs, lab tests, and ECG
  • Liver enzymes (AST, ALT) less than 1.5 times upper limit of normal
  • Total bilirubin and alkaline phosphatase less than 1.2 times upper limit of normal
  • White blood cell, platelet count, and hemoglobin within normal range or not clinically significant if abnormal
  • Normal coagulation tests (PT/INR, PTT, D-dimer adjusted for age)
  • Negative drug and alcohol tests at screening and check-in; willing to abstain from alcohol and recreational drugs during study
  • No tobacco or nicotine use within 3 months; negative cotinine test at screening and check-in; willing to abstain during study
  • Women of childbearing potential must use double-barrier contraception or abstinence and refrain from sperm/egg donation during study and for 3 months after last dose
  • Hormonal contraceptives and intrauterine devices must be stopped 3 months before first dose and during study and 3 months after last dose
  • Negative pregnancy tests at screening and check-in for females
  • Able to communicate and comply with study requirements
Not Eligible

You will not qualify if you...

  • Any significant acute or chronic medical condition that could interfere with the study
  • History of plastic surgery involving silicone
  • Significant illness, surgery, or trauma within 4 weeks before first dose or planned surgery during study that cannot be delayed
  • Abnormal physical exam, vital signs, labs, or ECGs considered clinically significant
  • Systolic blood pressure over 140 mm Hg or diastolic over 90 mm Hg after 10 minutes rest
  • Heart rate below 45 or above 100 beats per minute after rest
  • ECG abnormalities including prolonged QTcF, prolonged PR interval, AV block, bundle branch block, left ventricular hypertrophy, or family history of long QT syndrome or sudden cardiac death
  • Known allergy to CAY001 components or study medications
  • History of significant liver, spleen, or kidney disease
  • History of arterial or venous thrombosis or clotting disorders
  • Increased risk of bleeding including recent major bleeding events, hemorrhagic disorders, severe head trauma, or blood in stool
  • Use of prescription, investigational, or illicit drugs within 30 days before dosing
  • Use of over-the-counter, dietary supplements, or herbal products within 14 days before dosing through Day 7
  • Known active hepatitis B or C, HIV, or other immune deficiency
  • Pregnant or breastfeeding females or planning pregnancy within 3 months after last dose
  • History of alcoholism or drug addiction within 1 year
  • Recent blood transfusion or coagulation factors within 1 month before dosing
  • Prior exposure to CAY001
  • Employment or family relation to study sponsors or sites
  • Inability to understand or adhere to protocol
  • Consumption of caffeine 48 hours before check-in and during study confinement
  • Females actively menstruating on dosing day
  • Study enrollment already filled

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

TKL Research

Fair Lawn, New Jersey, United States, 07410

Actively Recruiting

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Research Team

I

Iris Moscoso, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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