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NCT00527865 · ClinicalTrials.gov registry record · Phase 1

Single Dose Escalating Study of DAS181 in Adults

A Phase 1 study, sponsored by Ansun Biopharma.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT00527865 is a Phase 1 study that has completed, run by Ansun Biopharma. The registered enrollment target is 36 participants.

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The verdict

NCT00527865, a Phase 1 study, has completed, sponsored by Ansun Biopharma.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study 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 up to 60 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 +/- 1 day, and 30 +/- 2 days. Participants will be involved in the study for up to 61 days, which includes the screening period.

Interventions

  • DRUG Placebo
  • DRUG DAS181

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2007-10
Est. Completion 2009-01
Phase Phase 1

Sponsor

Ansun Biopharma

8 total trials

What the Registry Record Tells You About NCT00527865

The ClinicalTrials.gov registry entry for NCT00527865 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ansun Biopharma, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00527865 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00527865 about?

NCT00527865 is a clinical study titled "Single Dose Escalating Study of DAS181 in 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 up to 60 healthy, non-smoking males ...

What is the current status of trial NCT00527865?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2007-10. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00527865?

The interventions under investigation include: Placebo (DRUG), DAS181 (DRUG).

Who is sponsoring clinical trial NCT00527865?

This trial is sponsored by Ansun Biopharma, which has 8 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.