Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003

Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of LIB003 in Healthy Subjects With Hypercholesterolemia on Diet or Statin Therapy

Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.

After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.

Inclusion Criteria:

• Men and women who are >/=18 and </=70 years of age. Female subjects must be of non-childbearing potential.
• LDL-C >/=100 mg/dL who are either not on a lipid-lowering therapy or who are on stable statin therapy.
• Body mass index (BMI) >18 and <38 kg/m2
• Mild hypertensives on a stable dose of no more than one antihypertensive drug

Exclusion Criteria:

• History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion
• Systolic blood pressure <90 mmHg or >160 mmHg or diastolic blood pressure <50 or >100 mmHg at screening
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody
• Abnormal liver function test at Screening (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × the upper limit of normal [ULN]
• Estimated glomerular filtration rate <60 mL/min/1.73 m2 at screening, as determined by the CKD-EPI Equation
• History of prescription drug abuse, illicit drug use (including marijuana), or alcohol abuse
• Unable to spend 4 days in confinement unit
• History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine
• Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study