Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 7/29/2018 |
| Start Date: | October 30, 2017 |
| End Date: | June 30, 2018 |
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
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.
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.
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.
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.
Inclusion Criteria:
- Men and women who are >/=18 and 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
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