Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

NCT01313962 | Completed Phase 1

• 1 other identifier: AIT02-11-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

antiviral; intranasal; influenza

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  2 weeks

Study Arms (2)

Flufirvitide-3

EXPERIMENTAL

Drug: Flufirvitide-3 0.05 mg single dose; Drug: Flufirvitide-3, 0.1 mg single dose; Drug: Flufirvitide-3, 0.2 mg single dose; Drug: Flufirvitide-3, 0.4 mg single dose

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Flufirvitide-3 0.05 mg single dose DRUG

Nasal Spray

Flufirvitide-3

Flufirvitide-3, 0.1 mg single dose DRUG

Nasal spray

Flufirvitide-3

Flufirvitide-3, 0.2 mg single dose DRUG

nasal spray

Flufirvitide-3

Flufirvitide-3, 0.4 mg single dose DRUG

Nasal spray

Flufirvitide-3

Placebo OTHER

Nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autoimmune Technologies, LLC: lead

Study Sites (1)

Quintiles Phase One Services

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Sam Hopkins, PhD

  Autoimmune Technologies, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: March 14, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 16, 2012

Record last verified: 2012-01

Locations

US (1)