Single Dose Escalating Study of DAS181 in Adults
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ClinicalTrials.gov Identifier: NCT00527865 |
Recruitment Status
:
Completed
First Posted
: September 11, 2007
Last Update Posted
: January 8, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Drug: DAS181 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study 181-1-06-01 - Phase 1A Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalating Study in Healthy Adults |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
6 subjects DAS181 dosage 0.5 mg; 3 subjects placebo
|
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 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Drug: Placebo
Capsules containing 10.5 mg of lactose will be supplied as placebo.
|
Experimental: 2
6 subjects DAS181 dosage 1.0 mg; 3 subjects placebo
|
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 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Drug: Placebo
Capsules containing 10.5 mg of lactose will be supplied as placebo.
|
Experimental: 3
6 subjects DAS181 dosage 2.25 mg; 3 subjects placebo
|
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 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Drug: Placebo
Capsules containing 10.5 mg of lactose will be supplied as placebo.
|
Experimental: 4
6 subjects DAS181 dosage 4.5 mg; 3 subjects placebo
|
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 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Drug: Placebo
Capsules containing 10.5 mg of lactose will be supplied as placebo.
|
- Safety and tolerability of a single-dose of DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. [ Time Frame: Duration of study ]
- The pharmacokinetic parameters of DAS181. [ Time Frame: Pre-dosing, 1, 2, 4, 6, 8, 12 and 24 hours post dosing, Day 2, and Day 7 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527865
United States, Florida | |
Comprehensive Phase One | |
Miramar, Florida, United States, 33025 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mang Yu, Nexbio, Inc |
ClinicalTrials.gov Identifier: | NCT00527865 History of Changes |
Obsolete Identifiers: | NCT00718900 |
Other Study ID Numbers: |
06-0082 181-1-06-01 |
First Posted: | September 11, 2007 Key Record Dates |
Last Update Posted: | January 8, 2009 |
Last Verified: | January 2009 |
Keywords provided by Ansun Biopharma, Inc.:
Influenza, Flu, DAS181, Fludase |