CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Interferon Beta-1Adrug
Likely dose
Interferon Beta-1A 60 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03614715
NCT03614715Phase 1Completed
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Comparative Trial of the Pharmacokinetics and Pharmacodynamics of Intramuscularly Injected CinnoVex® and Avonex® in Healthy Volunteers

Cinnagen·interventional·Posted Aug 3, 2018·Updated Jan 10, 2020

In Brief

A Phase 1 clinical trial evaluating Interferon Beta-1A for Bioequivalence and Healthy. Completed, enrolled 40 participants across 1 site.

Detailed 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®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence, Healthy
CountriesFinland
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartNov 27, 2017
Primary CompletionFeb 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago

Interventions

Interferon Beta-1Adrug

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)