NCT01863069

Avonex®: Safety, Blood Levels and Effects

A Single-centre Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Inhaled Formulation of AVONEX® (Interferon Beta-1a) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Trio Medicines Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective was to determine the tolerability of a new inhaled formulation of interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and compared with standard intramuscular (IM) AVONEX® when given as a single dose. The additional objectives were: To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose. To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose.

Conditions

• Multiple Sclerosis (MS)

Interventions

Type	Name	Description
DRUG	Interferon beta 1a
DRUG	(IM) AVONEX®

Timeline

• Start date: 2001-01-01
• Primary completion: 2001-10-01
• Completion: 2001-10-01
• First posted: 2013-05-27
• Last updated: 2013-05-27

Locations

1 site across 1 country: United Kingdom