Actively Recruiting
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
Led by Cayuga Biotech, Inc. · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001, a drug given intravenously. This first-in-human, randomized, double-blind, placebo-controlled study involves healthy male and female volunteers aged 18 to 50 years. The goal is to better understand how CAY001 behaves in the body and how safe it is at different dose levels. Participants will be randomly assigned to receive either CAY001 or a placebo. The study will test three different dose levels of CAY001 given as a single ascending dose to groups of subjects. Approximately 24 healthy volunteers will take part in this study. Each participant will be closely monitored during and after dosing to evaluate the effects and how the drug is processed in the body. During the study, researchers will perform physical exams, vital sign checks, electrocardiograms (ECGs), blood and urine tests, and other laboratory assessments to track changes from the start of the study through 28 days after dosing. Safety will be carefully monitored by recording any adverse events and changes in various health parameters. Pharmacokinetic measurements will also be taken up to 24 hours after dosing to understand the drug's behavior. Participants will be involved in scheduled visits and assessments throughout the study period to ensure their well-being and to collect necessary data.
CONDITIONS
Brief Title
Study to Evaluate CAY001 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Male or female (based on gender assigned at birth), aged 18 to 50 years inclusive
- Body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 61 kg
- In good general health as determined by medical history, vital signs, physical exam, lab tests, and ECG
- Specific lab values within normal or acceptable ranges including liver enzymes, bilirubin, blood counts, coagulation tests
- Negative drug and alcohol tests at screening and Day -1, and willing to abstain from alcohol and recreational drugs during the study
- No use of tobacco or nicotine products for at least 3 months, with negative cotinine test, and willing to abstain during the study
- Women of childbearing potential must use double-barrier contraception or abstinence and stop hormonal contraceptives or IUDs 3 months before and after dosing; negative pregnancy tests required
- Able to communicate and comply with study requirements throughout the study period
You will not qualify if you...
- Any clinically significant acute or chronic medical condition that could interfere with the study
- History of plastic surgery with silicone, recent significant illness, surgery, trauma within 4 weeks before dosing, or planned surgery during study that cannot be delayed
- Abnormal physical exam, vital signs, lab tests, or ECG findings that may interfere with the study
- Vital signs after 10 minutes rest: systolic BP >140 mm Hg, diastolic BP >90 mm Hg, heart rate <45 or >100 bpm
- ECG abnormalities including prolonged QTc, PR interval issues, AV block, bundle branch block, left ventricular hypertrophy, family history of long QT or sudden cardiac death
- Known allergy or hypersensitivity to CAY001 components or study medications
- History of significant liver, spleen, or kidney disease
- History of arterial or venous thrombosis or clotting disorders
- Increased bleeding risk including recent GI bleeding, brain or eye bleeding, major trauma, hemorrhagic disorders, or blood in stool
- Use of prescription, investigational, or illicit drugs within 30 days before dosing
- Use of OTC supplements or herbal products within 14 days before dosing through Day 7 follow-up
- Known active hepatitis B or C, HIV, or other immune deficiency
- Pregnant, planning pregnancy within 3 months after dosing, or breastfeeding
- History of alcoholism or drug addiction within 1 year
- Recent blood transfusion or coagulation factor use within 1 month
- Prior exposure to CAY001
- Employment or close relation to sponsor, investigator, or study site staff
- Unable to understand or follow study requirements
- Consumption of caffeine 48 hours before check-in and during confinement
- Women actively menstruating on dosing day
- Study enrollment full at time of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive a single intravenous dose of CAY001 or placebo and are monitored for safety and pharmacokinetics.
Multiple visits including baseline and follow-up assessments through Day 28
Trial Site Locations
Total: 1 location
1
TKL Research
Fair Lawn, New Jersey, United States, 07410
Actively Recruiting
Research Team
I
Iris Moscoso, CCRC
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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