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Clinical Trial 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®.

Clinical Trial 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 IFN╬▓-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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03614715
Study type Interventional
Source Cinnagen
Contact Morteza Azhdarzadeh, PharmD, PhD
Phone 0989144091359
Status Recruiting
Phase Phase 1
Start date November 27, 2017
Completion date February 15, 2019

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