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Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02423577
Enrollment
79
Registered
2015-04-22
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

antiviral, influenza, challenge

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.

Interventions

DRUGFF-3 dry powder

FF-3 dry powder administered by nasal inhalation

DRUGPlacebo

Placebo dry powder administered by nasal inhalation

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Autoimmune Technologies, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive 2. Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive and body weight of 50 to 110 kg inclusive. 3. Normal spirometry values at Screening and Baseline 4. Post-menopausal women with amenorrhea for at least 2 years will be eligible 5. 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: 6. 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. 7. Willing and able to provide written informed consent. 8. Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol

Exclusion criteria

* Subjects may not be enrolled in the study if any of the following

Design outcomes

Primary

MeasureTime frameDescription
Frequencies of Viral SheddingDay 2 to Day 10Percentage of Subjects Demonstrating Viral Shedding.

Countries

United Kingdom

Participant flow

Pre-assignment details

Potential subjects were screened to determine their susceptibility to infection with the challenge strain as indicated by a serum antibody titre less than 1:10. Only subjects susceptible to the challenge strain qualified for study specific screening.

Participants by arm

ArmCount
FF-3 Dry Powder
FF-3 FF-3 dry powder: FF-3 dry powder administered by nasal inhalation
53
Placebo
Placebo: Placebo dry powder administered by nasal inhalation
26
Total79

Baseline characteristics

CharacteristicFF-3 Dry PowderPlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
53 Participants26 Participants79 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants3 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants23 Participants72 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
3 Participants0 Participants3 Participants
Race (NIH/OMB)
More than one race
5 Participants2 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
43 Participants22 Participants65 Participants
Region of Enrollment
United Kingdom
53 Participants26 Participants79 Participants
Sex: Female, Male
Female
13 Participants12 Participants25 Participants
Sex: Female, Male
Male
40 Participants14 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 530 / 26
other
Total, other adverse events
46 / 5323 / 26
serious
Total, serious adverse events
0 / 530 / 26

Outcome results

Primary

Frequencies of Viral Shedding

Percentage of Subjects Demonstrating Viral Shedding.

Time frame: Day 2 to Day 10

Population: The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons's method)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
FF-3 Dry PowderFrequencies of Viral Shedding51 Participants
PlaceboFrequencies of Viral Shedding22 Participants
p-value: 0.143690% CI: [0.98, 1.31]Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026