Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT00876161
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2009-04-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DAS181 Single Dose Escalation Study in Healthy Adults
Sponsor:
Ansun Biopharma, Inc.
Organization:
Study Overview
Official Title:
Phase 1 Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Contract: HHSN266200600015CIb | None | None | View |