Status:
COMPLETED
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
Lead Sponsor:
LIB Therapeutics LLC
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin the...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05234775
Start Date
January 28 2022
End Date
July 11 2022
Last Update
July 14 2022
Active Locations (1)
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1
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227