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Lead
LIB Therapeutics LLC
With
Medpace, Inc.
Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Provision of written and signed informed consent prior to any study-specific procedure
LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
Females of childbearing potential must be using a highly effective form of birth control
Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control
You may not be if
Fasting triglyceride \>400 mg/dL
excluded lipid lowering medication
severe renal impairment (eGFR \<30 ml/min)
fasting glucose \>200 mg/dL plus HbA1c \>9%
hepatic transaminases \>2.5 x ULN for laboratory
History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
NYHA class III-IV heart failure or last documented left ventricular EF \<30%
Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject
Clareo Health | Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
