Dyslipidemia
Conditions
Brief summary
This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
Interventions
DRUGCAT 2003
DRUGPlacebo
Sponsors
Catabasis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Major Inclusion Criteria: * Provision of written informed consent prior to any study-specific procedure; * Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements; * Satisfies one of the following: 1. Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR 2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose; Major
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events | Screening to End of study (up to 4 weeks following randomization) |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf of CAT-2003 | Days 1, 7 and 14 |
| Cmax of CAT-1004 | Days 1, 7 and14 |
| Changes from baseline for Physical exams | Baseline through end of study (up to 4 weeks) |
| Changes from baseline for hematology, chemistry, coagulation and urinalysis | Baseline through End of study (up to 4 weeks) |
| Changes from baseline in vital signs | Baseline through end of study (up to 4 weeks) |
| Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia | Baseline to end of study (up to 4 weeks) |
| Changes from baseline for ECGs | Baseline through end of study (up to 4 weeks) |
Countries
United States
Outcome results
None listed