Hypercholesterolemia
Conditions
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 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
Interventions
DRUGlerodalcibep
300 mg of each drug given SC as single dose
Sponsors
Medpace, Inc.
LIB Therapeutics LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
assignment to initial treatment group with cross over to alternate treatment group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacodynamics | 4 weeks | comparison of free PCSK9 reductions from baseline between P1 and P2 |
| Cmax pharmacokinetics | 4 weeks | comparison of serum lerodalcibep Cmax between P1 and P2 |
| AUC 0-last pharmacokinetics | 4 weeks | comparison of serum lerodalcibep AUC 0-last between P1 and P2 |
| T-Half pharmacokinetics | 4 weeks | comparison of serum lerodalcibep T-HALF between P1 and P2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of LDL-C | 4 weeks | comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2 |
Countries
United States
Outcome results
None listed