NCT03545438

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

April 19, 2018

Last Update Submit

July 26, 2018

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of treatment emergent adverse events (TEAEs)

    safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events

    43 days

Secondary Outcomes (6)

  • Absolute change in serum unbound (free) proprotein convertase subtilisin/kexin type 9 (PCSK9) concentrations over time

    43 days

  • Absolute change in serum total PCSK9 over time

    43 days

  • Percent change in Low Density Lipoprotein cholesterol (LDL-C) over time

    43 days

  • Percent change in Apolipoprotein B (Apo B) over time

    43 days

  • Changes in serum LIB003 concentrations over time

    43 days

  • +1 more secondary outcomes

Study Arms (9)

cohort 1

PLACEBO COMPARATOR

LIB003 dose 1 SC

Biological: LIB003

cohort 2

PLACEBO COMPARATOR

LIB003 dose 2 SC

Biological: LIB003

cohort 3

PLACEBO COMPARATOR

LIB003 dose 4 SC

Biological: LIB003

cohort 4

PLACEBO COMPARATOR

LIB003 dose 4 SC

Biological: LIB003

cohort 5

PLACEBO COMPARATOR

LIB003 dose 5 SC

Biological: LIB003

cohort 6

PLACEBO COMPARATOR

LIB003 dose 4 IV

Biological: LIB003

cohort 7

PLACEBO COMPARATOR

LIB003 dose 5 IV

Biological: LIB003

cohort 8

PLACEBO COMPARATOR

LIB003 dose 3 SC - statin treated

Biological: LIB003

cohort 9

PLACEBO COMPARATOR

LIB003 dose 4 SC - statin treated

Biological: LIB003

Interventions

LIB003BIOLOGICAL

LIB003 or placebo

cohort 1cohort 2cohort 3cohort 4cohort 5cohort 6cohort 7cohort 8cohort 9

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 Ă— 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medpace (MARC/CPU)

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Traci A Turner, MD

    Medpace Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: single ascending dose with placebo controll
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

June 4, 2018

Study Start

October 30, 2017

Primary Completion

May 30, 2018

Study Completion

June 30, 2018

Last Updated

July 27, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)