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Official title Study to Evaluate CAY001 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06845839
What this study is testing
What is CAY001?
CAY001 is an investigational medicine, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- The subject is able to provide written informed consent
- The subject is male or female (based on gender assigned at birth), 18-50 years of age inclusive
- The subject has a body mass index ≥ 18 and ≤ 30.0 kg/m2 and weighs at least 61 kg for males and females
- The subject is in good general health per Investigator evaluation for age as determined by medical history, vital signs, physical examination...
- Aspartate transaminase (AST), alanine transaminase (ALT) \< 1.5 x upper limit of normal (ULN)
You likely can't join if
- Any clinically significant acute or chronic medical condition that in the evaluating Investigator's opinion could interfere with the study
- Any history of plastic surgery involving silicone, any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the...
- Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments (other than those discussed in the...
- Any of the following vital signs occurring after 10 minutes of supine rest at screening or check-in: ▪ Systolic blood pressure \>140 mm Hg ▪...
- Any of the following ECG parameters at screening or check-in:
- Prolonged Fridericia-corrected QT interval (QTcF) \>450 msec for males and \> 460 msec for females, shortened QTcF \ 3 seconds;
See the full eligibility criteria
Who can join
- The subject is able to provide written informed consent
- The subject is male or female (based on gender assigned at birth), 18-50 years of age inclusive
- The subject has a body mass index ≥ 18 and ≤ 30.0 kg/m2 and weighs at least 61 kg for males and females
- The subject is in good general health per Investigator evaluation for age as determined by medical history, vital signs, physical examination findings, screening laboratory test results, and 12-lead ECG results...
- 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
- 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;
- 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...
- Male and female (women of childbearing potential [WOCBP]) people of childbearing potential must agree to the double-barrier method (i.e. male condom and spermicide or diaphragm and spermicide) or abstinence and refrain...
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study
What rules you out
- Any clinically significant acute or chronic medical condition that in the evaluating Investigator's opinion could interfere with the study
- Any history of plastic surgery involving silicone, any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug or any planned surgical procedure...
- Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments (other than those discussed in the inclusion criteria), and ECG parameters identified during screening or...
- Any of the following vital signs occurring after 10 minutes of supine rest at screening or check-in: ▪ Systolic blood pressure \>140 mm Hg ▪ Diastolic blood pressure \>90 mmHg ▪ Heart rate \ 100 beats per minute
- Any of the following ECG parameters at screening or check-in:
- Prolonged Fridericia-corrected QT interval (QTcF) \>450 msec for males and \> 460 msec for females, shortened QTcF \ 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
- 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;
- Any history of significant liver, spleen, or kidney conditions
- 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;
- 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
- Use of any prescription, investigational or illicit drugs within 30 days (or 5 half-lives whichever is longer) prior to dosing;
- 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;
- Known active hepatitis B or C infection, human immunodeficiency virus (HIV) infection, or known other immune deficiency disease at screening;
- Females who are pregnant, plan to become pregnant within 3 months of the last dose of study drug, or are breastfeeding a child;
- History of or treatment for alcoholism or drug addiction within 1 year;
- Receipt of blood transfusion, blood-derived products, or coagulation factors within 1 month prior to Day 1;
- Prior exposure to CAY001;
- An employee, family member, or student of the Sponsor, Investigator, or clinical site(s);
- Unable to adhere to or understand the requirements of the protocol.
- Consume caffeine containing food or beverages 48 hours prior to check in and during study confinement period.
- Females who are actively menstruating on the day of dosing (Day 1).
- Subject meets eligibility criteria, but study is filled.
The study team makes the final eligibility decision.
Where it's taking place
- Fair Lawn, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fair Lawn, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.