Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

NCT ID: NCT01313962

Last Updated: 2012-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-01-31

Brief Summary

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Flufirvitide-3

Group Type: EXPERIMENTAL

Flufirvitide-3, 0.1 mg single dose

Intervention Type: DRUG

Nasal spray

Flufirvitide-3, 0.2 mg single dose

Intervention Type: DRUG

nasal spray

Flufirvitide-3 0.05 mg single dose

Intervention Type: DRUG

Nasal Spray

Flufirvitide-3, 0.4 mg single dose

Intervention Type: DRUG

Nasal spray

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Nasal spray

Interventions

Flufirvitide-3, 0.1 mg single dose

Nasal spray

Intervention Type: DRUG

Flufirvitide-3, 0.2 mg single dose

nasal spray

Intervention Type: DRUG

Flufirvitide-3 0.05 mg single dose

Nasal Spray

Intervention Type: DRUG

Flufirvitide-3, 0.4 mg single dose

Nasal spray

Intervention Type: DRUG

Placebo

Nasal spray

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Autoimmune Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Hopkins, PhD

Role: STUDY_DIRECTOR

Autoimmune Technologies, LLC

Locations

Quintiles Phase One Services

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

AIT02-11-01

Identifier Type: -

Identifier Source: org_study_id