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OpenTrials
Completed

NCT Number: NCT03545438

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace (MARC/CPU)

Cincinnati, Ohio, 45227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIB003

Biological

LIB003 or placebo

Primary outcomes

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

    Time frame: 43 days

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

Secondary outcomes

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

    Time frame: 43 days

    Serum free PCSK9 will be measured at baseline and various time points over 43 days

  2. Absolute change in serum total PCSK9 over time

    Time frame: 43 days

    Serum total PCSK9 will be measured at baseline and various time points over 43 days

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

    Time frame: 43 days

    Serum LDL-C will be measured at baseline and various time points over 43 days to derive percent change

  4. Percent change in Apolipoprotein B (Apo B) over time

    Time frame: 43 days

    Serum Apo B will be measured at baseline and various time points over 43 days to derive percent change

  5. Changes in serum LIB003 concentrations over time

    Time frame: 43 days

    serum LIB003 will be measured at various time points to derive AUC (area under curve)

  6. Presence of anti LIB003 antibodies (ADAs)

    Time frame: 43 days

    Measurement of ADAs will be done at baseline and various intervals after LIB003 administration

Sponsors and collaborators

Lead sponsor

LIB Therapeutics LLC

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of LIB003 in Healthy Subjects With Hypercholesterolemia on Diet or Statin Therapy

Acronym: LIB003SAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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