NCT05234775

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

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 2 (P2) in subjects with or without statin therapy

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	lerodalcibep	300 mg of each drug given SC as single dose

Timeline

• Start date: 2022-01-28
• Primary completion: 2022-06-30
• Completion: 2022-07-11
• First posted: 2022-02-10
• Last updated: 2022-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study