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

NCT03545438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-07-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

LIB003

LIB003 or placebo

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • LIB Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Traci A Turner, MD · Medpace Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-05-30
Completion
2018-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545438 on ClinicalTrials.gov