Title
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
Phase
Phase 1Lead Sponsor
LIB Therapeutics LLCStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HypercholesterolemiaIntervention/Treatment
LIB003Study Participants
63Randomized, 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
