Clinical trial NCT01725594: A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
Official title: A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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;

Primary outcomes:
measure: Frequency and severity of adverse events
timeFrame: Screening to End of study (up to 4 weeks following randomization)
Secondary outcomes:
measure: AUCinf of CAT-2003
timeFrame: Days 1, 7 and 14
measure: Cmax of CAT-1004
timeFrame: Days 1, 7 and14
measure: Changes from baseline for hematology, chemistry, coagulation and urinalysis
timeFrame: Baseline through End of study (up to 4 weeks)
measure: Changes from baseline for Physical exams
timeFrame: Baseline through end of study (up to 4 weeks)
measure: Changes from baseline for ECGs
timeFrame: Baseline through end of study (up to 4 weeks)
measure: Changes from baseline in vital signs
timeFrame: Baseline through end of study (up to 4 weeks)
measure: 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
timeFrame: Baseline to end of study (up to 4 weeks)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace CPU
state: Ohio
Study officials:
affiliation: Medpace, Inc.
name: Lukasz Biernat, M.D
role: PRINCIPAL_INVESTIGATOR
References: