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

Autoimmune Technologies, LLC1 site in 1 country79 target enrollmentSeptember 2015

ConditionsInfluenza

InterventionsFF-3 dry powder Placebo

DrugsFF-3 dry powder Placebo

Overview

Phase: Phase 2
Intervention: FF-3 dry powder
Conditions: Influenza
Sponsor: Autoimmune Technologies, LLC
Enrollment: 79
Locations: 1
Primary Endpoint: Frequencies of Viral Shedding
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

June 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Autoimmune Technologies, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive
•Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive and body weight of 50 to 110 kg inclusive.
•Normal spirometry values at Screening and Baseline
•Post-menopausal women with amenorrhea for at least 2 years will be eligible
•Females of childbearing potential must use two acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:
•Male subjects:
•Must agree to use a condom (or diaphragm) plus spermicide in female partner) from the time of the first dose of IMP through 90 days after the last dose.
•Must agree to not donate sperm for 90 days after the last dose of IMP.
•Documented evidence of vasectomies in males for 180 days minimum prior to the first dose of the IMP is an acceptable form of contraception.
•Males who claim abstinence as their method of contraception are allowed provided they agree to use a double barrier method (diaphragm plus spermicide in female partner or condom) should they become sexually active from screening to 90 days after the last dose of IMP.

Exclusion Criteria

•Subjects may not be enrolled in the study if any of the following exclusion criteria are fulfilled:
•Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine , or psychiatric disease.
•Current infection of any nature unless agreed as insignificant to the study by the Investigator and Medical Monitor.
•Nasal abnormalities, including nasal septum deviation, septum perforations, or polyps; history of recurrent epistaxis; history of sinus surgery and/or persistent hypertrophic inferior turbinates.
•Significant abnormalities at screening in safety laboratory tests, ECGs, or spirometry.
•Broncho-reactive airway disease (asthma, chronic obstructive pulmonary disease, current allergic rhinitis, cystic fibrosis, chronic bronchitis, emphysema). Individuals with a history of childhood asthma are not necessarily excluded and acceptable for screening.
•History of significant nasal irritation from use of nasal sprays or drops.
•History of drug or alcohol abuse within the past 2 years
•Nicotine product users
•Received an investigational drug or participated in another research study within 90 days of the first dose of IMP.