Medpace (MARC/CPU)
Cincinnati, Ohio, 45227, United States
NCT Number: NCT03545438
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Cincinnati, Ohio, 45227, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LIB003 or placebo
Time frame: 43 days
safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
Time frame: 43 days
Serum free PCSK9 will be measured at baseline and various time points over 43 days
Time frame: 43 days
Serum total PCSK9 will be measured at baseline and various time points over 43 days
Time frame: 43 days
Serum LDL-C will be measured at baseline and various time points over 43 days to derive percent change
Time frame: 43 days
Serum Apo B will be measured at baseline and various time points over 43 days to derive percent change
Time frame: 43 days
serum LIB003 will be measured at various time points to derive AUC (area under curve)
Time frame: 43 days
Measurement of ADAs will be done at baseline and various intervals after LIB003 administration
LIB Therapeutics LLC
Industry
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
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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