Study of CAY001 in Healthy Volunteers
This study is testing a new drug called CAY001, which is a polyphosphate (PolyP) - silica nanoparticle (SNP) complex. We want to understand if CAY001 is safe and how your body handles it. You may be eligible if you are a healthy male or female between 18 and 50 years old, with a BMI between 18 and 30, and weigh at least 61 kg. We will be looking at any side effects you might have and how severe they are for 28 days after you receive the drug. This study aims to enroll about 24 healthy volunteers.
- Study design
- This is a Phase 1, first-in-human study. It is randomized, double-blind (meaning neither you nor the study team will know if you receive CAY001 or a placebo), and will involve about 24 healthy participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for 28 days after receiving the study drug or placebo.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06845839
Study to Evaluate CAY001 in Healthy Volunteers
Recruiting
PHASE1Ages 18–50InterventionalTreatmentCayuga Biotech, Inc.
~24 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:CAY001Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of serious adverse events from Baseline through Day 28.
Measured over 28 days
+21 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNew Jersey1
Study leadership
- Charles Pollack, MD · STUDY_DIRECTOR · Cayuga Biotech, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Aspartate transaminase (AST), alanine transaminase (ALT) \< 1.5 x upper limit of normal (ULN)
Total serum bilirubin and alkaline phosphatase levels \< 1.2 x ULN
White blood cell (WBC) count, platelet count, and hemoglobin level within the normal range; out of range values are allowed if per the Investigator they are not deemed clinically significant
PT/INR, partial thromboplastin time (PTT), and D-dimer level (age-adjusted) within the normal range 5. Negative drug and alcohol tests at Screening and check-in (Day -1) and willing to abstain from alcohol and recreational drug use from the screening visit until the EOS/ET Visit; 6. No use of any tobacco or nicotine-containing products within 3 months, negative cotinine test at Screening and check-in (Day -1), and willing to abstain from tobacco or nicotine use from the screening visit until the EOS/ET Visit; 7. Male and female (women of childbearing potential \[WOCBP\]) subjects of childbearing potential must agree to the double-barrier method (i.e. male condom and spermicide or diaphragm and spermicide) or abstinence and refrain from sperm/egg donation throughout the study starting with the first dose of study treatment and for at least 3 months after the last dose of study drug. Hormonal contraceptives and intrauterine devices \[IUD\] must be stopped at least 3 months prior to the first dose of study treatment and for at least 3 months after the last dose of study drug. ▪ Note: Non-WOCBP includes healthy postmenopausal women who have undergone surgical menopause (hysterectomy, oophorectomy) or have been naturally menopausal, with no menstrual cycle for at least 24 months prior to Day 1; In the case of females, a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy test at check-in on Day -1. 8. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study
Prolonged Fridericia-corrected QT interval (QTcF) \>450 msec for males and \> 460 msec for females, shortened QTcF \<340 msec, or pause \>3 seconds;
Prolonged PR (PQ) interval \>200 msec, intermittent second- or third-degree atrioventricular (AV) block or AV dissociation
Complete right or left bundle branch block (QRS \> 120 msec); left ventricular hypertrophy
Family history of long QT syndrome or sudden cardiac death 6. Have a known hypersensitivity or allergy to CAY001 components polyP or SNP, or to any ingredients in medication(s) to be received in this study; 7. Any history of significant liver, spleen, or kidney conditions 8. Any history of arterial or venous thrombosis or hypercoagulable or thrombotic condition, including any of the following
History of transient ischemic attack, cardiovascular accident, stroke (ischemic or hemorrhagic), unstable angina, myocardial infarction, or peripheral arterial disease
History of deep venous thrombosis, pulmonary embolus, thrombophlebilitis or arterial thrombosis
History of known clotting disorders like factor V leiden syndrome, protein C or S deficiency, or antiphospholipid syndrome; 9. An increased risk of bleeding, including but not limited to the following:
Recent history (within 6 months preceding the first dose of study drug) of gastrointestinal (GI) bleeding that required unscheduled medical evaluation;
History of intracranial, intraocular, retroperitoneal, or spinal bleeding;
Recent major trauma (within 6 months preceding the first dose of the study drug)
History of hemorrhagic disorders, e.g. hemophilia, von Willebrand's disease, Hermansky-Pudlak syndrome
History of severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy;
Subject reported history of blood in the stool 10. Use of any prescription, investigational or illicit drugs within 30 days (or 5 half-lives whichever is longer) prior to dosing; 11. Use of any over-the-counter (OTC) products, dietary supplements and herbal products (ie. St. John's Wort or fish oil) within 14 days of dosing through the Day 7 Safety Follow-up Visit; 12. Known active hepatitis B or C infection, human immunodeficiency virus (HIV) infection, or known other immune deficiency disease at screening; 13. Females who are pregnant, plan to become pregnant within 3 months of the last dose of study drug, or are breastfeeding a child; 14. History of or treatment for alcoholism or drug addiction within 1 year; 15. Receipt of blood transfusion, blood-derived products, or coagulation factors within 1 month prior to Day 1; 16. Prior exposure to CAY001; 17. An employee, family member, or student of the Sponsor, Investigator, or clinical site(s); 18. Unable to adhere to or understand the requirements of the protocol. 19. Consume caffeine containing food or beverages 48 hours prior to check in and during study confinement period. 20. Females who are actively menstruating on the day of dosing (Day 1). 21. Subject meets eligibility criteria, but study is filled.
What this trial measures
- Incidence and severity of serious adverse events from Baseline through Day 28.28 days
- Incidence and severity of treatment related adverse events from Baseline through Day 2828 days
- Changes in physical examination findings from Baseline through Day 2828 days
Physical examination includes general appearance, HEENT (head, eyes, ears, nose, throat), chest/lungs, heart, abdominal, neurological, extremities, skin, and palpable lymph nodes. Physical examination will be conducted at screening, at multiple timepoints during the study (symptom-directed).
- Changes in electrocardiograms (ECGs) from Baseline through Day 2828 days
A standard 12-lead ECG will be performed after at least 10 minutes in the supine position. ECG data collected includes PR, QT interval, QRS duration, QTcF and heart rate.
- Changes in systolic and diastolic blood pressure in mmHg from Baseline through Day 2828 days
Vital signs, including blood pressure will be collected with the subject supine and after resting for 10 minutes.
- Changes in blood chemistry parameters (calcium, phosphorus, glucose, BUN, uric acid, bilirubin, creatinine and magnesium) in mg/dL, from Baseline through Day 2828 days
- Changes in hematology parameters (white blood cell, red blood cell, platelets) in x10E3/uL, from Baseline through Day 2828 days
- Changes in coagulation parameters (aPTT and PT) in seconds, from Baseline through Day 2828 days
- Changes in urinalysis from Baseline through Day 2828 days
Urinalysis evaluations are microscopic examination and specific gravity, pH, protein, glucose, ketones, blood, urobilinogen, bilirubin, nitrites and leucocyte values.
- Changes in temperature in degrees Celsius from Baseline through Day 2828 days
Vital signs, including temperature, will be collected with the subject supine and after resting for 10 minutes.
- Changes in pulse in beats per minute, from Baseline through Day 2828 days
Vital signs, including pulse, will be collected with the subject supine and after resting for 10 minutes.
- Changes in respiratory rate in breaths per minute, from Baseline through Day 2828 days
Vital signs, including respiratory rate, will be collected with the subject supine and after resting for 10 minutes.
- Changes in blood chemistry (total protein, albumin) in g/dL, from Baseline through Day 2828 days
- Changes in blood chemistry (alkaline phosphatase, AST, ALT, GGT ) in IU/dL, from Baseline through Day 2828 days
- Changes in blood chemistry (creatinine kinase, ) in U/L, from Baseline through Day 2828 days
- Changes in blood chemistry (potassium, sodium, chloride) in mmol/L, from Baseline through Day 2828 days
- Changes in hematology parameters (hemoglobin, MCHC) in g/dL, from Baseline through Day 2828 days
- Changes in hematocrit in % from Baseline through Day 2828 days
- Changes in hematology parameter, MCV, in fL from Baseline through Day 2828 days
- Changes in hematology parameter, MCH in pg from Baseline through Day 2828 days
- Changes in coagulation parameter, D-Dimer, in mg/L FEU, from Baseline through Day 2828 days
- Changes in coagulation parameter, INR, in NA, from Baseline through Day 2828 days