Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003

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

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2018-06-30

Brief Summary

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Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.

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Detailed Description

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After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

single ascending dose with placebo controll

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Within each dosing cohort randomization is performed according to a computer-generated randomization scheme. Other than the study drug prepared by an unblinded pharmacist and administered by unblinded nurses who will be instructed not to discuss randomized treatment assignments and have no other role in the study, all study staff and PI, along with the subjects are blinded as to treatment.

Intervention Type BIOLOGICAL

LIB003 or placebo

Interventions

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LIB003

LIB003 or placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men and women who are \>/=18 and \</=70 years of age. Female subjects must be of non-childbearing potential.
* LDL-C \>/=100 mg/dL who are either not on a lipid-lowering therapy or who are on stable statin therapy.
* Body mass index (BMI) \>18 and \<38 kg/m2
* Mild hypertensives on a stable dose of no more than one antihypertensive drug

Exclusion Criteria

* History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion
* Systolic blood pressure \<90 mmHg or \>160 mmHg or diastolic blood pressure \<50 or \>100 mmHg at screening
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody
* Abnormal liver function test at Screening (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × the upper limit of normal \[ULN\]
* Estimated glomerular filtration rate \<60 mL/min/1.73 m2 at screening, as determined by the CKD-EPI Equation
* History of prescription drug abuse, illicit drug use (including marijuana), or alcohol abuse
* Unable to spend 4 days in confinement unit
* History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine
* Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes