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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2022-07-11

Brief Summary

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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

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Detailed Description

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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

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

assignment to initial treatment group with cross over to alternate treatment group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LIB003 (lerodalcibep) Process 1

300 mg LIB003 Process 1 drug product administered SC

Group Type EXPERIMENTAL

lerodalcibep

Intervention Type DRUG

300 mg of each drug given SC as single dose

LIB003 (lerodalcibep) Process 2

300 mg LIB003 Process 2 drug product administered SC

Group Type ACTIVE_COMPARATOR

lerodalcibep

Intervention Type DRUG

300 mg of each drug given SC as single dose

Interventions

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lerodalcibep

300 mg of each drug given SC as single dose

Intervention Type DRUG

Other Intervention Names

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LIB003

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes