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Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

Hypercholesterolemia Clinical Trial

Official title:
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy

Clinical Trial 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 therapy

Clinical Trial 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 2 (P2) in subjects with or without statin therapy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05234775
Study type Interventional
Source LIB Therapeutics LLC
Contact
Status Completed
Phase Phase 3
Start date January 28, 2022
Completion date July 11, 2022
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