Clinical trial NCT01313962: Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: antiviral
intranasal
influenza
Lead sponsor: Autoimmune Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles Phase One Services
state: Kansas
Study officials:
affiliation: Autoimmune Technologies, LLC
name: Sam Hopkins, PhD
role: STUDY_DIRECTOR
References: