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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- pharmacodynamics
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
LIB003 (lerodalcibep) Process 1
300 mg LIB003 Process 1 drug product administered SC
Intervention: lerodalcibep (Drug)
LIB003 (lerodalcibep) Process 2
300 mg LIB003 Process 2 drug product administered SC
Intervention: lerodalcibep (Drug)
Outcomes
Primary Outcomes
pharmacodynamics
Time Frame: 4 weeks
comparison of free PCSK9 reductions from baseline between P1 and P2
Cmax pharmacokinetics
Time Frame: 4 weeks
comparison of serum lerodalcibep Cmax between P1 and P2
AUC 0-last pharmacokinetics
Time Frame: 4 weeks
comparison of serum lerodalcibep AUC 0-last between P1 and P2
T-Half pharmacokinetics
Time Frame: 4 weeks
comparison of serum lerodalcibep T-HALF between P1 and P2
Secondary Outcomes
- comparison of LDL-C(4 weeks)