A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
Hypercholesterolemia
About this trial
This is an interventional other trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent before any study-specific procedure
- Good health as determined by medical history, physical examination, vital sign measurements, ECG, and clinical laboratory measurements
Satisfies one of the following:
- Females not of childbearing potential: non-pregnant and non-lactating surgically sterile or postmenopausal 2 years or less with a follicle-stimulating hormone assessment greater than or equal to 40 IU/L
- Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose
- For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL
- Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18 and 40 kg/m², inclusive, for Part B, and body weight >50 kg at Screening
Exclusion Criteria:
- Use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing. Additionally for Part B only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF >450
- Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer
Sites / Locations
- Spaulding Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort A1, Dose Level 1: CAT-2054 or placebo fasting
Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed
Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed
Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed
Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed
Cohort B1, Dose Level 1: CAT-2054 or placebo
Cohort B2, Dose Level 2: CAT-2054 or placebo
Cohort B3, Dose Level 3: CAT-2054 or placebo
Cohort B4, Dose Level 4: CAT-2054 or placebo
Cohort B5, Dose Level 5: CAT-2054 or placebo
Cohort B6, Dose Level 6: CAT-2054 with atorvastatin
Cohort B7, Dose Level 7: CAT-2054 or placebo
Single dose
Single dose
Single dose
Single dose
Single dose
Multiple dose for 14 days
Multiple dose for 14 days
Multiple dose for 14 days
Multiple dose for 14 days
Multiple dose for 14 days
Multiple dose for 14 days
Multiple dose for 14 days