NCT00876161

DAS181 Single Dose Escalation Study in Healthy Adults

Phase 1 Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DAS181	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.
DRUG	Lactose

Timeline

• Start date: 2009-05-18
• Primary completion: 2009-12-01
• Completion: 2010-05-23
• First posted: 2009-04-06
• Last updated: 2019-08-02

Locations

1 site across 1 country: United States