Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Summary

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab 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 (mepolizumab or reslizumab) or placebo.

Conditions

• Healthy Subjects
• Pharmacokinetics
• Pharmacodynamics

Interventions

BIOLOGICAL

Mepolizumab

Mepolizumab 3 mg administered SC

BIOLOGICAL

Mepolizumab

Mepolizumab 6 mg administered SC

BIOLOGICAL

Mepolizumab

Mepolizumab 12 mg administered SC

BIOLOGICAL

Mepolizumab

Mepolizumab 24 mg administered SC

BIOLOGICAL

Reslizumab

Reslizumab 0.1 mg/kg administered IV

BIOLOGICAL

Reslizumab

Reslizumab 0.2 mg/kg administered IV

BIOLOGICAL

Reslizumab

Reslizumab 0.4 mg/kg administered IV

BIOLOGICAL

Reslizumab

Reslizumab 0.8 mg/kg administered IV

BIOLOGICAL

Placebo

Placebo (administered either IV or SC)

Sponsors & Collaborators

• Spaulding Clinical Research LLC

  collaborator OTHER

• Food and Drug Administration (FDA)

  lead FED

Principal Investigators

• Jennifer Deering, MSN, APNP · 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

2020-02-17

Primary Completion

2021-04-04

Completion

2021-04-04

FDA Drug

Yes

Countries

• United States

Study Locations