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Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

NCT04189484 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-04-22

Study results available
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Summary

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.

This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

Conditions

  • Healthy Subjects
  • Pharmacokinetics
  • Pharmacodynamics

Interventions

BIOLOGICAL

Evolocumab

Evolocumab 21 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 35 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 70 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 140 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 15 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 25 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 50 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 100 mg administered SC

BIOLOGICAL

Placebo

Placebo administered SC

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Colleen Nalepinski, MPAS, PA-C · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2021-04-07
Completion
2021-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04189484 on ClinicalTrials.gov