Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
Completed · Phase 1 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT03545438
- Run by
- LIB Therapeutics LLC
- People needed
- 63
- Starts
- 2017-10-30
- Expected to finish
- 2018-06-30
- Last updated by the study team
- 2018-07-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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…
- 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
Where it is running
- Medpace (MARC/CPU) — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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