NCT04183192

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Mepolizumab doses are 3, 6, 12, or 24 mg. Reslizumab doses are 0.1, 0.2, 0.4, or 0.8 mg/kg. Each arm will include 8 subjects (4 male and 4 female). Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Depending on the treatment arm, subjects will remain in confinement for two weeks and continue follow-up through either day 63 or day 123. Blood samples (approximately 5 mL per sample) will be collected for determination of plasma concentrations for study drug. Additional blood samples will be collected for determination of eosinophil counts (5 mL per sample; pharmacodynamic measure) and exploratory proteomics analyses (5 mL per sample). Safety evaluations will include adverse event (AE) monitoring, vital sign measurements, and physical examinations. All AEs reported by the subject or observed by the investigator or clinical research unit (CRU) staff will be recorded. Any AE reported after the informed consent is signed and before study drug application will be recorded as medical history.

Conditions

• Healthy Subjects
• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-02-17
• Primary completion: 2021-04-04
• Completion: 2021-04-04
• First posted: 2019-12-03
• Last updated: 2024-04-22
• Results posted: 2024-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study