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Sponsors and Collaborators: |
NexBio, Inc National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | NexBio, Inc |
ClinicalTrials.gov Identifier: | NCT00876161 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: DAS181 Drug: Lactose |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study in Healthy Adults |
Estimated Enrollment: | 29 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DAS181: Experimental |
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.
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Lactose: Placebo Comparator | Drug: Lactose |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
If this is within the provided range, then subject may be enrolled.
Exclusion Criteria:
Contact: Denise Kelley | 800-292-5533 | volunteer@quintiles.com |
United States, Kansas | |
Quintiles Phase One Services | |
Overland Park, Kansas, United States, 66211 |
Responsible Party: | Quintiles Phase One Services ( Patricia A. Meier, MD ) |
Study ID Numbers: | DAS181-1-02, Contract: HHSN266200600015CIb |
Study First Received: | April 3, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00876161 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy Adults |
Healthy |