NCT04183491

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (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 interferon beta-1a and peginterferon beta-1a 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 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

Detailed description

This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a 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 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo. Interferon beta-1a doses are 7.5, 15, and 30 µg. Peginterferon beta-1a doses are 31.25, 62.5, and 125 µg. Each arm will include 12 subjects (6 male and 6 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 7 days (interferon beta-1a) or 14 days (peginterferon beta-1a and placebo). Blood samples (approximately 5 mL per sample) will be collected for determination of plasma concentrations for study drug and neopterin levels. Additional blood samples will be collected for determination of lipids (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	Interferon beta-1a	Interferon beta-1a 7.5 µg administered IM
BIOLOGICAL	Interferon beta-1a	Interferon beta-1a 15 µg administered IM
BIOLOGICAL	Interferon beta-1a	Interferon beta-1a 30 µg administered IM
BIOLOGICAL	Peginterferon beta-1a	Peginterferon beta-1a 31.25 µg administered SC
BIOLOGICAL	Peginterferon beta-1a	Peginterferon beta-1a 62.5 µg administered SC
BIOLOGICAL	Peginterferon beta-1a	Peginterferon beta-1a 125 µg administered SC
BIOLOGICAL	Placebo	Placebo (administered either IM or SC)

Timeline

• Start date: 2020-02-28
• Primary completion: 2021-01-26
• Completion: 2021-01-26
• 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