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NCT02423577
A Phase 2a, Randomized, Double-blind, Placebo-controlled Assessment of the Safety and Protective Efficacy of FF-3 Dry Powder Administered by Nasal Inhalation for 5 Days to Healthy Adult Subjects Who Are Experimentally Infected With a Challenge Strain of Influenza A Virus
Phase 2 trial testing FF-3 dry powder in Influenza in 79 participants. Completed in 1 June 2016.
1 June 2016
Quick facts
| Lead sponsor | Autoimmune Technologies, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 79 |
| Start date | 1 September 2015 |
| Primary completion | 1 June 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- FF-3 dry powder — full drug profile →
- Placebo
Conditions studied
- Influenza — all drugs for Influenza →
Sponsor
Autoimmune Technologies, LLC — full company profile →
Who can join
Adults 18 to 50, any sex, with Influenza. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Frequencies of Viral Shedding
Time frame: Day 2 to Day 10
Percentage of Subjects Demonstrating Viral Shedding.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02423577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02423577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Autoimmune Technologies, LLC
- Last refreshed: 11 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02423577.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing