MedTrace Logo

Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

NCT05234775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-07-14

No results posted yet for this study

Summary

To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy

Conditions

Interventions

DRUG

lerodalcibep

300 mg of each drug given SC as single dose

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • LIB Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Traci A Turner, MD · Metabolic & Atherosclerosis Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2022-06-30
Completion
2022-07-11
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 NCT05234775 on ClinicalTrials.gov