Multiple Sclerosis (MS) Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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