Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a)
Condition: Bioequivalence; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to investigate the biosimilarity of CinnoVex® by
      comparing its pharmacokinetics (PK) and pharmacodynamics (PD) to its originator, Avonex®, in
      a crossover manner in healthy female and male volunteers after administration of a single
      dose of 30 µg or 60 µg of Interferon beta-1a.

      The secondary objectives of the study are:

        -  To further compare the PK of CinnoVex® and Avonex®.

        -  To further compare the PD of CinnoVex® and Avonex®.

        -  To assess the safety of CinnoVex®.
    

Detailed description: 
      This trial will be a double-blind, randomised, active-controlled, single-centre, two-stage
      crossover trial with administration of single doses of CinnoVex® and Avonex®. Stage 1
      includes comparison of 30 µg and 60 µg IM doses in 16 healthy volunteers (eight subjects on
      each dose level, each subject will be administered one dose of each product as 30 µg or 60 µg
      doses in a crossover manner and in randomised order). After interim analysis of the PK and PD
      results of these 16 subjects and evaluation of the data by an expert data monitoring
      committee (DMC), Stage 2 will investigate the selected dose. The sample size of Stage 2 will
      be determined in the interim analysis so that a sufficient number of additional healthy
      volunteers are added to one or both dose levels to ensure adequate statistical power for the
      study's objectives, to evaluate biosimilarity. Up to 48 additional healthy volunteers may be
      added at this stage.

      Subjects will undergo screening assessments before their first treatment visit. A total of 16
      healthy volunteers will be selected for Stage 1 and 24 or 48 will be selected for Stage 2
      according to the inclusion and exclusion criteria. To reveal possible differences in the
      trial outcomes between the sexes, approximately equal numbers of male and female subjects
      will be included. The trial will be performed in healthy adult volunteers with a maximum age
      of 45 years, to limit variability that may result from including older adults.

      Eligibility of subjects will be confirmed prior to each IMP administration with a pregnancy
      test (female subjects with childbearing potential), a urine drug screen and an alcohol breath
      test. In addition, the subjects will be asked about current illnesses, subjective well-being,
      and concomitant medications. A physical examination will take place, if indicated.

      The subjects will participate in 2 treatment periods in sequential order; treatment period 1
      starts when the first IMP is administered and treatment period 2 starts when the second IMP
      is administered. The two treatment administrations of individual subjects will be separated
      by at least 14 days.

      Blood samples will be collected prior to and at scheduled time points after the IMP
      administration. Plasma concentrations of IFNβ-1a and concentrations of the selected
      biomarkers in serum and blood will be determined. The total volume of blood collected from
      each subject during the trial is less than 500 ml.

      Safety will be assessed by recording blood pressure (BP), heart rate (HR), body temperature
      and subjective symptoms at scheduled time points after IMP administration. AEs and
      concomitant medications will be recorded throughout the trial.
    

Intervention name(s): Interferon Beta-1A
Intervention type(s): Drug
Intervention description(s): A single dose of Interferon Beta-1A (Stage 1: 30 or 60 µg, stage 2: 30 µg) was administered IM to healthy subjects (cross over treatment)
Other intervention name(s): CinnoVex; Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other