Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
Condition: Healthy Subjects; Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Interferon beta-1a; Interferon beta-1a; Interferon beta-1a; Peginterferon beta-1a; Peginterferon beta-1a; Peginterferon beta-1a; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Interferon beta-1a 7.5 µg administered IM; Interferon beta-1a 15 µg administered IM; Interferon beta-1a 30 µg administered IM; Peginterferon beta-1a 31.25 µg administered SC; Peginterferon beta-1a 62.5 µg administered SC; Peginterferon beta-1a 125 µg administered SC; Placebo (administered either IM or SC)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics; Pharmacodynamics