drugset / Trial / NCT02423577
Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain
Phase 2
Completed
79 enrolled
Autoimmune Technologies, LLC
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus.
Timeline
- Start
- 2015-09
- Primary completion
- 2016-06
- Completion
- 2016-06
Outcome
Missed primary endpoint
registry analysis (superiority test); FF-3 Dry Powder vs Placebo; p = 0.1436; Risk Ratio (RR) 1.14 (90% CI 0.98 to 1.31); Chi-squared NCT02423577 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FF-3 | Unknown | — | Intranasal |