Avonex®: Safety, Blood Levels and Effects (C-851)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01863069|
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis (MS)||Drug: Interferon beta 1a Drug: (IM) AVONEX®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Single-centre Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Inhaled Formulation of AVONEX® (Interferon Beta-1a) in Healthy Volunteers|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
- Drug: Interferon beta 1a
Other Name: AVONEX
- Drug: (IM) AVONEX®
- Pharmacokinetic parameter [ Time Frame: 10 months ]Serum concentrations of human interferon-beta
- Pharmacodynamic parameter [ Time Frame: 10 months ]Serum concentrations of neopterin and beta2-microglobulin
- Number of adverse events [ Time Frame: 10 months ]Adverse events throughout the study
- Clinically relevant changes from baseline in safety assessments [ Time Frame: 10 months ]Routine physical examination, ECG, safety tests of blood/urine, CXR, oximetry, full pulmonary function tests, spirometry, Dyspnea scale
- Pharmacodynamic paramter [ Time Frame: 10 months ]Cellular MxA protein as an exploratory analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863069
|Hammersmith Medicines Research|
|London, United Kingdom, NW10 7EW|
|Principal Investigator:||Steve Warrington||Hammersmith Medicines Research|