Expired Study
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Overland Park, Kansas 66211


Purpose:

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


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


NCT ID:

NCT01313962


Primary Contact:

Study Director
Sam Hopkins, PhD
Autoimmune Technologies, LLC


Backup Contact:

N/A


Location Contact:

Overland Park, Kansas 66211
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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