safety study of flufirvitide-3 nasal spray in healthy subjects

Conditions: Influenza

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


Eligibility criteria:
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

Keywords: antiviral intranasal influenza