Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Autoimmune Technologies, LLC

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