DAS181 Single Dose Escalation Study in Healthy Adults
This study will evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Study participants will include healthy non-smoking males and females, ages 18-65. They will be given either DAS181 or placebo. Participants will remain in the clinic overnight to be watched for health changes for 24 hours after receiving the medication. Study procedures include: physical exams, chest x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs. Follow-up visits will occur on study days 2, 7, 14 and 30.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1 Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study in Healthy Adults|
- To evaluate the safety, tolerability and pharmacokinetics of DAS181 dry powder inhalant single-dose treatment in healthy adults. [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 5 mg, 10 mg and 20 mg.
|Placebo Comparator: Lactose||Drug: Lactose|
|United States, Kansas|
|Quintiles Phase One Services|
|Overland Park, Kansas, United States, 66211|