Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

Autoimmune Technologies, LLC

Status and phase

Completed

Phase 1

Conditions

Influenza

Treatments

Drug: Flufirvitide-3, 0.1 mg single dose

Other: Placebo

Drug: Flufirvitide-3, 0.4 mg single dose

Drug: Flufirvitide-3 0.05 mg single dose

Drug: Flufirvitide-3, 0.2 mg single dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT01313962

AIT02-11-01

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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