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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
300 mg of each drug given SC as single dose
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
pharmacodynamics
comparison of free PCSK9 reductions from baseline between P1 and P2
Time frame: 4 weeks
Cmax pharmacokinetics
comparison of serum lerodalcibep Cmax between P1 and P2
Time frame: 4 weeks
AUC 0-last pharmacokinetics
comparison of serum lerodalcibep AUC 0-last between P1 and P2
Time frame: 4 weeks
T-Half pharmacokinetics
comparison of serum lerodalcibep T-HALF between P1 and P2
Time frame: 4 weeks
comparison of LDL-C
comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2
Time frame: 4 weeks
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