Study to Evaluate CAY001 in Healthy Volunteers (NCT06845839) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate CAY001 in Healthy Volunteers
United States24 participantsStarted 2025-12-02
Plain-language 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. Three dose levels will be evaluated with a total of approximately 24 subjects.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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
What they're measuring
1
Incidence and severity of serious adverse events from Baseline through Day 28.
Timeframe: 28 days
2
Incidence and severity of treatment related adverse events from Baseline through Day 28
Timeframe: 28 days
3
Changes in physical examination findings from Baseline through Day 28
Timeframe: 28 days
4
Changes in electrocardiograms (ECGs) from Baseline through Day 28
Timeframe: 28 days
5
Changes in systolic and diastolic blood pressure in mmHg from Baseline through Day 28
Timeframe: 28 days
6
Changes in blood chemistry parameters (calcium, phosphorus, glucose, BUN, uric acid, bilirubin, creatinine and magnesium) in mg/dL, from Baseline through Day 28
Timeframe: 28 days
7
Changes in hematology parameters (white blood cell, red blood cell, platelets) in x10E3/uL, from Baseline through Day 28
✕. 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:
✕. 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
Changes in coagulation parameters (aPTT and PT) in seconds, from Baseline through Day 28
Timeframe: 28 days
9
Changes in urinalysis from Baseline through Day 28
Timeframe: 28 days
10
Changes in temperature in degrees Celsius from Baseline through Day 28
Timeframe: 28 days
11
Changes in pulse in beats per minute, from Baseline through Day 28
Timeframe: 28 days
12
Changes in respiratory rate in breaths per minute, from Baseline through Day 28
Timeframe: 28 days
13
Changes in blood chemistry (total protein, albumin) in g/dL, from Baseline through Day 28
Timeframe: 28 days
14
Changes in blood chemistry (alkaline phosphatase, AST, ALT, GGT ) in IU/dL, from Baseline through Day 28
Timeframe: 28 days
15
Changes in blood chemistry (creatinine kinase, ) in U/L, from Baseline through Day 28
Timeframe: 28 days
16
Changes in blood chemistry (potassium, sodium, chloride) in mmol/L, from Baseline through Day 28
Timeframe: 28 days
17
Changes in hematology parameters (hemoglobin, MCHC) in g/dL, from Baseline through Day 28
Timeframe: 28 days
18
Changes in hematocrit in % from Baseline through Day 28
Timeframe: 28 days
19
Changes in hematology parameter, MCV, in fL from Baseline through Day 28
Timeframe: 28 days
20
Changes in hematology parameter, MCH in pg from Baseline through Day 28
Timeframe: 28 days
21
Changes in coagulation parameter, D-Dimer, in mg/L FEU, from Baseline through Day 28
Timeframe: 28 days
22
Changes in coagulation parameter, INR, in NA, from Baseline through Day 28