Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Autoimmune Technologies, LLC
ClinicalTrials.gov Identifier:
NCT01313962
First received: February 16, 2011
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Influenza
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
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Autoimmune Technologies, LLC:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flufirvitide-3 Drug: Flufirvitide-3 0.05 mg single dose
Nasal Spray
Drug: Flufirvitide-3, 0.1 mg single dose
Nasal spray
Drug: Flufirvitide-3, 0.2 mg single dose
nasal spray
Drug: Flufirvitide-3, 0.4 mg single dose
Nasal spray
Placebo Comparator: Placebo Other: Placebo
Nasal spray

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313962

Locations
United States, Kansas
Quintiles Phase One Services
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Autoimmune Technologies, LLC
Investigators
Study Director: Sam Hopkins, PhD Autoimmune Technologies, LLC
  More Information

No publications provided

Responsible Party: Autoimmune Technologies, LLC
ClinicalTrials.gov Identifier: NCT01313962     History of Changes
Other Study ID Numbers: AIT02-11-01
Study First Received: February 16, 2011
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Autoimmune Technologies, LLC:
antiviral
intranasal
influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014