Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958
Lead Sponsor:
Biota Scientific Management Pty Ltd
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 year...
Detailed Description
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups.Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths an...
Eligibility Criteria
Inclusion
- Male and Female subjects aged 18 to 55 years, inclusive
Exclusion
- Pregnant or lactating female subjects.
- Out of range findings in vital signs, physical examination, or lab tests.
- Intake of any investigational drug within the 4 months prior to Day 0.
- Positive urine drug screen or alcohol breath test.
- Significant disease, event, or condition which may impact on subject safety or study compliance.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00995826
Start Date
April 1 2009
End Date
November 1 2009
Last Update
May 30 2018
Active Locations (1)
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1
Covance Clinical Research Unit Limited
Leeds, United Kingdom