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Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a)

NCT03614715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-10

No results posted yet for this study

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®.

Conditions

  • Bioequivalence
  • Healthy

Interventions

DRUG

Interferon Beta-1A

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)

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Mika Scheinin, MD, PhD · CRST, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-02-12
Completion
2019-02-12

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614715 on ClinicalTrials.gov