Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

Influenza Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313962
• Other study ID #: AIT02-11-01
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2011
• Last updated: January 12, 2012
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Autoimmune Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• Flufirvitide-3 0.05 mg single dose
Nasal Spray
• Flufirvitide-3, 0.1 mg single dose
Nasal spray
• Flufirvitide-3, 0.2 mg single dose
nasal spray
• Flufirvitide-3, 0.4 mg single dose
Nasal spray

Other:
• Placebo
Nasal spray

Locations

Country	Name	City	State
United States	Quintiles Phase One Services	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Autoimmune Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		2 weeks	Yes