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

• ClinicalTrials.gov Identifier: NCT02423577
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Results First Posted: August 14, 2017
• Last Update Posted: August 14, 2017
• Sponsor: Autoimmune Technologies, LLC
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Autoimmune Technologies, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Drug: FF-3 dry powder; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: September 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: FF-3 dry powder; FF-3	Drug: FF-3 dry powder; FF-3 dry powder administered by nasal inhalation
Placebo Comparator: Placebo	Drug: Placebo; Placebo dry powder administered by nasal inhalation

Outcome Measures

Primary Outcome Measures :

1. Frequencies of Viral Shedding [ Time Frame: Day 2 to Day 10 ]
   Percentage of Subjects Demonstrating Viral Shedding.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 exclusion criteria are fulfilled:

  1. Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine , or psychiatric disease.
  2. Current infection of any nature unless agreed as insignificant to the study by the Investigator and Medical Monitor.
  3. Nasal abnormalities, including nasal septum deviation, septum perforations, or polyps; history of recurrent epistaxis; history of sinus surgery and/or persistent hypertrophic inferior turbinates.
  4. Significant abnormalities at screening in safety laboratory tests, ECGs, or spirometry.
  5. 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.
  6. History of significant nasal irritation from use of nasal sprays or drops.
  7. History of drug or alcohol abuse within the past 2 years
  8. Nicotine product users
  9. Received an investigational drug or participated in another research study within 90 days of the first dose of IMP.
  10. Participated in a previous investigational study of FF-3.
  11. History of influenza vaccination with a live or attenuated vaccine within the previous year
  12. Use of prescription drugs within 14 days prior to the first dose of IMP, excepting oral contraceptives.
  13. Received any non-prescription medications, vitamins, or dietary supplements within 14 days of administration of the first dose of IMP, unless both the Principal Investigator and the Medical Monitor grant prior approval. Herbal supplements must be discontinued 7 days prior to the first dose of IMP.

  15. Tested positive for alcohol at screening or admission to the CRU. 16. Positive urine pregnancy test at the Screening Visit or positive serum pregnancy test on admission to the CRU (females only).

  17. Positive test for HIV, hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (anti-HCV) at the screening visit.

  18. Positive urine drug test at the screening visit or at admission to the CRU. 19. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

  20. Subjects who have donated blood or experienced other significant blood loss within 56 days of screening for the study.

Contacts and Locations

Locations

United Kingdom

Quintiles Drug Research Unit

London, United Kingdom

Sponsors and Collaborators

Autoimmune Technologies, LLC

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

• Responsible Party: Autoimmune Technologies, LLC
• ClinicalTrials.gov Identifier: NCT02423577
• Other Study ID Numbers: AIT02-2001; 2015-001103-31 ( EudraCT Number ); HHSN272201400003C ( Other Grant/Funding Number: National Institute of Health, NIAID ); DMID 14-0052 ( Other Identifier: Division of Microbiology and Infectious Diseases )
• First Posted: April 22, 2015
• Results First Posted: August 14, 2017
• Last Update Posted: August 14, 2017
• Last Verified: August 2017

Keywords provided by Autoimmune Technologies, LLC:

antiviral; influenza; challenge

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases