Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Part of paid clinical trials in West Bend, Wisconsin.

Sponsor
Food and Drug Administration (FDA)
Study ID
NCT04189484
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects
  • Pharmacodynamics
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Evolocumab 21 mg administered SC
  • Evolocumab — BIOLOGICAL
    Evolocumab 35 mg administered SC
  • Evolocumab — BIOLOGICAL
    Evolocumab 70 mg administered SC
  • Evolocumab — BIOLOGICAL
    Evolocumab 140 mg administered SC
  • Alirocumab — BIOLOGICAL
    Alirocumab 15 mg administered SC
  • Alirocumab — BIOLOGICAL
    Alirocumab 25 mg administered SC
  • Alirocumab — BIOLOGICAL
    Alirocumab 50 mg administered SC
  • Alirocumab — BIOLOGICAL
    Alirocumab 100 mg administered SC
  • Placebo — BIOLOGICAL
    Placebo administered SC

Study Details

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.

Key Dates

Start date
Jan 7, 2020
Status verified
Nov 2023
Primary completion
Apr 7, 2021
Completion
Apr 7, 2021

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Arm A: Evolocumab low dose
    Single dose of evolocumab 21 mg subcutaneous (SC)
  • Experimental: Arm B: Evolocumab intermediate low dose
    Single dose of evolocumab 35 mg SC
  • Experimental: Arm C: Evolocumab intermediate high dose
    Single dose of evolocumab 70 mg SC
  • Experimental: Arm D: Evolocumab high dose
    Single dose of evolocumab 140 mg SC
  • Experimental: Arm E: Alirocumab low dose
    Single dose of alirocumab 15 mg SC
  • Experimental: Arm F: Alirocumab intermediate low dose
    Single dose of alirocumab 25 mg SC
  • Experimental: Arm G: Alirocumab intermediate high dose
    Single dose of alirocumab 50 mg SC
  • Experimental: Arm H: Alirocumab high dose
    Single dose of alirocumab 100 mg SC
  • Placebo Comparator: Arm I: Placebo
    Single dose of placebo SC

Primary Outcome Measure

Baseline-adjusted Area Under Effect Curve (AUEC) for LDL-C for Evolocumab and Alirocumab [ Time Frame: Day -1 and 0h (pre-dose), 24h (post-dose); once on Day 2, 3, 4, 5, 7, 10, 14, 21, 28, 35, and 42 for all Arms. Additionally, once on Day 56 for Arms C, D, G, H, & I; and once on Day 70 and 84 for Arms D, H, & I. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Clinical ResearchWest BendWisconsin53095-

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Spaulding Clinical Research· West Bend, WI

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