Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01863069
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2013-05-20
Brief Title:
Avonex Safety Blood Levels and Effects
Sponsor:
Trio Medicines Ltd
Organization:
Trio Medicines Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-851
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None