Influenza
Conditions
Keywords
antiviral, intranasal, influenza
Brief summary
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.
Interventions
DRUGFlufirvitide-3 0.05 mg single dose
Nasal Spray
DRUGFlufirvitide-3, 0.1 mg single dose
Nasal spray
DRUGFlufirvitide-3, 0.2 mg single dose
nasal spray
DRUGFlufirvitide-3, 0.4 mg single dose
Nasal spray
OTHERPlacebo
Nasal spray
Sponsors
Autoimmune Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 2 weeks |
Countries
United States
Outcome results
None listed