Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza

Influenza Clinical Trial

Official title:

A Phase 2a, Double-Blind, Placebo-Controlled Study TCN 032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Subjects Challenged With H3N2 Influenza A Virus

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01719874
• Other study ID #: TCN-032-002
• Status: Unknown status
• Phase: Phase 2
• First received: October 25, 2012
• Last updated: October 30, 2012
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2012
• Source: Theraclone Sciences, Inc.
• Contact: Jennifer L. Mitcham
• Phone: 206-805-1608
• Email: jmitcham[@]theraclone-sciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy adult volunteers that have been inoculated with the influenza A virus

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 64
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18 to 45 years, inclusive.

• In good health with no history of major medical conditions

• Female subjects must not be pregnant or nursing

• Have not been vaccinated for influenza virus since 2006

• Serosusceptible to the challenge virus

• Non-smoker or current smoker willing/able to desist

Exclusion Criteria:

• Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness

• History or evidence of autoimmune disease

• Any history during adulthood of asthma, history of COPD, pulmonary hypertension, reactive airway disease, any chronic lung condition of any etiology), or any use of a bronchodilator or other asthma medication within adulthood

• History or clinical evidence of recurrent lower respiratory tract infection

• Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen

• Subject is diabetic

• History of frequent epistaxis (nose bleeds)

• Any nasal or sinus surgery within 6 months of the screening visit

• Recent and/or recurrent history of autonomic dysfunction (fainting, palpitations, etc.)

• Any laboratory test, ECG or spirometry which is abnormal and which is deemed by the Investigator(s) to be clinically significant.

• Any acute medical condition or significant past medical history of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, haematological, locomotor, immunologic, ophthalmologic, metabolic, endocrine, or other diseases

• Major surgery within 3 months prior to screening visit

• Evidence of drug of abuse or positive urine Class A drug or alcohol screen prior to admission

• Subjects symptomatic with hay fever

• Subjects with a history of significant adverse reactions/allergies

• History of allergy or intolerance to oseltamivir or zanamivir.

• Health care workers (including doctors, nurses, medical students, and allied healthcare professionals) anticipated to have patient contact within 2 weeks of viral challenge.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• TCN-032

• Placebo (saline)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Theraclone Sciences, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of clinical signs and symptoms of influenza (including upper respiratory, lower respiratory, systemic and fever).		7 days
Secondary	The main secondary objective is to evaluate the effect of TCN-032 compared to placebo in total virus shedding (measured by area under the curve [AUC]) from the nasal mucosa, measured by viral culture.		7 days
Secondary	Pharmacokinetics (PK) and immunogenicity of TCN-032		up to 28 days after viral challenge
Secondary	Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.		28 days after viral challenge
Secondary	Development of viral resistance to TCN-032		up to 9 days after viral challenge
Secondary	To evaluate the safety of subjects who undergo influenza A viral challenge, with or without treatment with TCN-032.		up to 28 days after viral challenge
Secondary	The duration of influenza symptoms or pyrexia		up to 10 days
Secondary	The time to peak of influenza symptoms or pyrexia		up to 10 days
Secondary	The daily incidence of influenza symptoms or pyrexia.		up to 10 days
Secondary	The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.		7 days
Secondary	The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.		7 days
Secondary	The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.		7 days
Secondary	The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.		7 days
Secondary	The proportion of any grade influenza symptoms, or pyrexia		7 days
Secondary	The duration of any grade influenza symptoms, or pyrexia		7 days
Secondary	The time to peak of any grade influenza symptoms, or pyrexia		7 days
Secondary	The daily incidence of any grade influenza symptoms, or pyrexia		7 days
Secondary	The peak value of virus shedding from the nasal mucosa measured by viral culture		up to 9 days
Secondary	The time to peak of virus shedding from the nasal mucosa measured by viral culture		up to 9 days
Secondary	The duration of virus shedding from the nasal mucosa measured by viral culture		up to 9 days
Secondary	The daily incidence of virus shedding from the nasal mucosa measured by viral culture		up to 9 days
Secondary	The AUC of virus shedding from the nasal mucosa measured by qPCR		6 days
Secondary	The peak value of virus shedding from the nasal mucosa measured by qPCR		6 days
Secondary	The time to peak of virus shedding from the nasal mucosa measured by qPCR		6 days
Secondary	The duration of virus shedding from the nasal mucosa measured by qPCR		6 days
Secondary	The daily incidence of virus shedding from the nasal mucosa measured by qPCR		6 days
Secondary	Incidence of seroconversion to viral challenge strain		up to 28 days after viral challenge
Secondary	Incidence of seroprotection to viral challenge strain		up to 28 days after viral challenge
Secondary	Total tissue count and total mucus weight after viral inoculation		7 days