Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects
Safety Study 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.
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