HealthyPhase 1NCT06845839
Study to Evaluate CAY001 in Healthy Volunteers
A Phase 1 study testing CAY001 in people with Healthy, run by Cayuga Biotech, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CAY001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 30 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to 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.
- Specific inclusionary laboratory values prior to randomization require the following.
- Aspartate transaminase (AST), alanine transaminase (ALT) \< 1.5 x upper limit of normal (ULN)
Show all 13Show fewer
- 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 EOS/ET Visit;
- 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.
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study
Who cannot join
- 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 that will occur during the study and cannot be delayed (from screening through the Day 28 EOS/ET Visit);
- 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 check-in that in the evaluating Investigator's opinion could interfere with the study. Note: abnormal test results may be repeated once for confirmation;
- 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 \<45 or \>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 \<340 msec, or pause \>3 seconds;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TKL Research
Fair Lawn, New Jersey, 07410
Iris Moscoso, CCRC, 201-587-0500 ext. 2524, irios@tklresearch.onmicrosoft.com
Cary Chiang, MD
About this study
Official title: 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
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
- Healthy
- Being tested
- CAY001, Placebo
- Keywords
- hemorrhage, polyphosphate, hemostatic drug, coagulation, clotting
- Medical subject headings
- Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAY001Drug
Polyphosphate (PolyP) - silica nanoparticle (SNP) complex
PlaceboOther
Vehicle - aqueous solution
| Study group | Role | What they receive |
|---|---|---|
| CAY001 | Experimental | Not described Receives: Drug: CAY001 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of serious adverse events from Baseline through Day 28.
Measured: 28 days
Incidence and severity of treatment related adverse events from Baseline through Day 28
Measured: 28 days
Changes in physical examination findings from Baseline through Day 28
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).
Measured: 28 days
Changes in electrocardiograms (ECGs) from Baseline through Day 28
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.
Measured: 28 days
Changes in systolic and diastolic blood pressure in mmHg from Baseline through Day 28
Vital signs, including blood pressure will be collected with the subject supine and after resting for 10 minutes.
Measured: 28 days
Changes in blood chemistry parameters (calcium, phosphorus, glucose, BUN, uric acid, bilirubin, creatinine and magnesium) in mg/dL, from Baseline through Day 28
Measured: 28 days
Changes in hematology parameters (white blood cell, red blood cell, platelets) in x10E3/uL, from Baseline through Day 28
Measured: 28 days
Changes in coagulation parameters (aPTT and PT) in seconds, from Baseline through Day 28
Measured: 28 days
Changes in urinalysis from Baseline through Day 28
Urinalysis evaluations are microscopic examination and specific gravity, pH, protein, glucose, ketones, blood, urobilinogen, bilirubin, nitrites and leucocyte values.
Measured: 28 days
Changes in temperature in degrees Celsius from Baseline through Day 28
Vital signs, including temperature, will be collected with the subject supine and after resting for 10 minutes.
Measured: 28 days
Changes in pulse in beats per minute, from Baseline through Day 28
Vital signs, including pulse, will be collected with the subject supine and after resting for 10 minutes.
Measured: 28 days
Changes in respiratory rate in breaths per minute, from Baseline through Day 28
Vital signs, including respiratory rate, will be collected with the subject supine and after resting for 10 minutes.
Measured: 28 days
Changes in blood chemistry (total protein, albumin) in g/dL, from Baseline through Day 28
Measured: 28 days
Changes in blood chemistry (alkaline phosphatase, AST, ALT, GGT ) in IU/dL, from Baseline through Day 28
Measured: 28 days
Changes in blood chemistry (creatinine kinase, ) in U/L, from Baseline through Day 28
Measured: 28 days
Changes in blood chemistry (potassium, sodium, chloride) in mmol/L, from Baseline through Day 28
Measured: 28 days
Changes in hematology parameters (hemoglobin, MCHC) in g/dL, from Baseline through Day 28
Measured: 28 days
Changes in hematocrit in % from Baseline through Day 28
Measured: 28 days
Changes in hematology parameter, MCV, in fL from Baseline through Day 28
Measured: 28 days
Changes in hematology parameter, MCH in pg from Baseline through Day 28
Measured: 28 days
Changes in coagulation parameter, D-Dimer, in mg/L FEU, from Baseline through Day 28
Measured: 28 days
Changes in coagulation parameter, INR, in NA, from Baseline through Day 28
Measured: 28 days
Secondary outcomes (9)
Change in calibrated automated thrombogram-thrombin generation assay (CAT-TGA) from Baseline through Day 28
CAT-TGA is an ex vivo assay to determine the speed and amount of thrombin generated.
Measured: 28 days
Determine the half-life (t½) (terminal)
Pharmacokinetic assay
Measured: Pre-dose through 24 hours post-dose
Determine the time to maximum concentration (Tmax)
Measured: Pre-dose through 24 hours post-dose
Determine the maximum observed concentration (Cmax)
Measured: Pre-dose through 24 hours post-dose
Determine the area under the curve (AUC)
Measured: Pre-dose through 24 hours post-dose
Determine the AUC zero to infinity (AUC0-∞)
Measured: Pre-dose through 24 hours post-dose
Determine the AUC zero to last measurable concentration (AUC0-last)
Measured: Pre-dose through 24 hours post-dose
Determine the clearance (CL)
Measured: Pre-dose through 24 hours post-dose
Determine the volume of distribution at steady state (Vss)
Measured: Pre-dose through 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start2 Dec 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cayuga Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Pollack, MD, Study director, Cayuga Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845839
- Sponsor's protocol ID
- CAY001-01
- Other IDs
- MT21006.078, MTEC-21-06-MPAI-078
- Status last verified
- May 2026
- First submitted
- 8 Nov 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06845839
- Acronym / sponsor ID
- CAY001-01
- Conditions
- Healthy
- Keywords
- hemorrhage, polyphosphate, hemostatic drug, coagulation, clotting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cayuga Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAY001 | Experimental | Drug: CAY001 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
- Specific inclusionary laboratory values prior to randomization require the following.
Key exclusion criteria (34 listed)
- 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 that will occur during the study and cannot be delayed (from screening through the Day 28 EOS/ET Visit);
- 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 check-in that in the evaluating Investigator's opinion could interfere with the study. Note: abnormal test results may be repeated once for confirmation;
- 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 \<45 or \>100 beats per minute
- Any of the following ECG parameters at screening or check-in:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAY001Polyphosphate (PolyP) - silica nanoparticle (SNP) complex | Drug | CAY001 |
| PlaceboVehicle - aqueous solution | Other | Placebo |
Primary outcome
Incidence and severity of serious adverse events from Baseline through Day 28.
Time frame: 28 days
Incidence and severity of treatment related adverse events from Baseline through Day 28
Time frame: 28 days
Changes in physical examination findings from Baseline through Day 28
Time frame: 28 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 28
Time frame: 28 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 28
Time frame: 28 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 28
Time frame: 28 days
Changes in hematology parameters (white blood cell, red blood cell, platelets) in x10E3/uL, from Baseline through Day 28
Time frame: 28 days
Changes in coagulation parameters (aPTT and PT) in seconds, from Baseline through Day 28
Time frame: 28 days
Changes in urinalysis from Baseline through Day 28
Time frame: 28 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 28
Time frame: 28 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 28
Time frame: 28 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 28
Time frame: 28 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 28
Time frame: 28 days
Changes in blood chemistry (alkaline phosphatase, AST, ALT, GGT ) in IU/dL, from Baseline through Day 28
Time frame: 28 days
Changes in blood chemistry (creatinine kinase, ) in U/L, from Baseline through Day 28
Time frame: 28 days
Changes in blood chemistry (potassium, sodium, chloride) in mmol/L, from Baseline through Day 28
Time frame: 28 days
Changes in hematology parameters (hemoglobin, MCHC) in g/dL, from Baseline through Day 28
Time frame: 28 days
Changes in hematocrit in % from Baseline through Day 28
Time frame: 28 days
Changes in hematology parameter, MCV, in fL from Baseline through Day 28
Time frame: 28 days
Changes in hematology parameter, MCH in pg from Baseline through Day 28
Time frame: 28 days
Changes in coagulation parameter, D-Dimer, in mg/L FEU, from Baseline through Day 28
Time frame: 28 days
Changes in coagulation parameter, INR, in NA, from Baseline through Day 28
Time frame: 28 days
9 secondary outcomes
Change in calibrated automated thrombogram-thrombin generation assay (CAT-TGA) from Baseline through Day 28
Time frame: 28 days
Determine the half-life (t½) (terminal)
Time frame: Pre-dose through 24 hours post-dose
Determine the time to maximum concentration (Tmax)
Time frame: Pre-dose through 24 hours post-dose
Determine the maximum observed concentration (Cmax)
Time frame: Pre-dose through 24 hours post-dose
Determine the area under the curve (AUC)
Time frame: Pre-dose through 24 hours post-dose
Determine the AUC zero to infinity (AUC0-∞)
Time frame: Pre-dose through 24 hours post-dose
Determine the AUC zero to last measurable concentration (AUC0-last)
Time frame: Pre-dose through 24 hours post-dose
Determine the clearance (CL)
Time frame: Pre-dose through 24 hours post-dose
Determine the volume of distribution at steady state (Vss)
Time frame: Pre-dose through 24 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Pollack, MD study director
Cayuga Biotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAY001 in people with Healthy, run by Cayuga Biotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Moscoso, CCRC (201-587-0500 ext. 2524, irios@tklresearch.onmicrosoft.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of serious adverse events from Baseline through Day 28. (time frame: 28 days). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.