Safety Study of Bile Acid to Treat Hypercholesteremia

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AtheroNova Inc.

Criteria

Key Inclusion Criteria:

• Males OR infertile Females

• 18-70 years of age, inclusive

• Asymptomatic mild to moderate hypercholesterolemia, (LDL =110-220 mg/dL)

• Cohort 5: on no statin or on a stable statin dose not meeting LDL >110 mg%

Key Exclusion criteria

• Fasting triglycerides <90 or >250 mg/dl (<0.85 mmol/l or >2.8 mmol/l)

• Body Mass Index (BMI) <18 or >34 kg/m2

• Diabetes mellitus (FBS > 125 mg% (>6.94 mmol/l)

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN

• Serum creatinine >ULN for gender

• Hemoglobin <11.5 g/dL

• Female volunteers of childbearing potential

• History of cancer in past 5 years

• Any disease requiring medication

• Use of investigational medication in past 3 months

• Positive results for illegal drugs, HBsAg, HBsAb, HCV or HIV

• Cohort 5:Prescription lipid lowering medications other than a statin in past 4 wks

• Cohort 5: History of gastrointestinal tract surgical resection