Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects

The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: Flufirvitide-3 0.05 mg single dose; Drug: Flufirvitide-3, 0.1 mg single dose; Drug: Flufirvitide-3, 0.2 mg single dose; Drug: Flufirvitide-3, 0.4 mg single dose; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Quintiles Phase One Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study-specific procedures.
• Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
• Healthy male and non-fertile female subjects aged 18 and 55 years inclusive
• Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential
• Male subjects should be willing to use barrier contraception during sexual intercourse,
• Body weight 50 to 100 kg inclusive and body mass index (BMI) 18 to 30 kg/m2 inclusive.
• Clinically non-significant findings on physical examination in relation to age.
• Negative Rapid Flu Test (TRU FLU® kit)
• Negative nasal examination upon admission to the study center.

Exclusion Criteria:

• History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders,
• History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject
• History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center.
• Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps.
• Subjects with a history of sinus surgery and/or persistent hypertrophic inferior turbinates.
• History of vaccination with live vaccine within 7 days or attenuated vaccine within 14 days of the administration of the investigational product.
• Any clinically significant abnormalities in clinical laboratory safety assessment results
• A positive result at screening on serum hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies.
• Significant orthostatic reaction at screening or upon admission to the study center as judged by the Principal Investigator.
• Abnormal vital signs, after 5 minutes supine rest,
• Any clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) that may interfere with the interpretation of QTc interval changes.
• Prolonged QTcF greater than 450 ms or shortened QTcF less than 360 ms or family history of long QT syndrome.
• Known or suspected drugs of abuse or alcohol abuse or dependence
• Positive screen for drugs of abuse or alcohol at screening or upon admission to the study center.
• Excessive intake of caffeine-containing foods or beverages within 48 hours prior to the admission to the study center.
• Use of drugs with enzyme-inducing properties such as St John's Wort, within 3 weeks prior to the administration of the investigational product.
• Abstain from smoking from 30 days prior to screening and for the duration of the study.
• Use of any prescribed medication as well as any over-the-counter/non prescribed/ herbal medicines, within 2 weeks prior to administration of the investigational product.
• Use of any nasal steroid 3 months prior to the administration of the investigational product.
• Involvement in the planning and/or conduct of the study
• Have received another new chemical entity or has participated in any other clinical study that included drug treatment within 3 months prior to administration of the investigational product in this study.
• Previous randomization of treatment in the present study or any other study with Flufirvitide-3.
• Plasma donation within 4 weeks prior to enrollment or blood donation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Nasal spray
Experimental: Flufirvitide-3	Drug: Flufirvitide-3 0.05 mg single dose; Nasal Spray; Drug: Flufirvitide-3, 0.1 mg single dose; Nasal spray; Drug: Flufirvitide-3, 0.2 mg single dose; nasal spray; Drug: Flufirvitide-3, 0.4 mg single dose; Nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	2 weeks

Collaborators and Investigators

• Sponsor: Autoimmune Technologies, LLC
• Investigators: Study Director: Sam Hopkins, PhD, Autoimmune Technologies, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: March 10, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2012
• Last Update Submitted That Met QC Criteria: January 12, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: influenza; intranasal; antiviral
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: AIT02-11-01