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

October 30, 2012 updated by: Theraclone Sciences, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TCN-032
single-dose, administered intravenously
Biological: TCN-032
PLACEBO_COMPARATOR: Placebo (saline)
single-dose, administered intravenously
Biological: Placebo (saline)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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).
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
Time Frame: 7 days
7 days
Pharmacokinetics (PK) and immunogenicity of TCN-032
Time Frame: up to 28 days after viral challenge
up to 28 days after viral challenge
Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.
Time Frame: 28 days after viral challenge
28 days after viral challenge
Development of viral resistance to TCN-032
Time Frame: up to 9 days after viral challenge
up to 9 days after viral challenge
To evaluate the safety of subjects who undergo influenza A viral challenge, with or without treatment with TCN-032.
Time Frame: up to 28 days after viral challenge
up to 28 days after viral challenge
The duration of influenza symptoms or pyrexia
Time Frame: up to 10 days
up to 10 days
The time to peak of influenza symptoms or pyrexia
Time Frame: up to 10 days
up to 10 days
The daily incidence of influenza symptoms or pyrexia.
Time Frame: up to 10 days
up to 10 days
The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time Frame: 7 days
7 days
The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time Frame: 7 days
7 days
The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time Frame: 7 days
7 days
The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time Frame: 7 days
7 days
The proportion of any grade influenza symptoms, or pyrexia
Time Frame: 7 days
7 days
The duration of any grade influenza symptoms, or pyrexia
Time Frame: 7 days
7 days
The time to peak of any grade influenza symptoms, or pyrexia
Time Frame: 7 days
7 days
The daily incidence of any grade influenza symptoms, or pyrexia
Time Frame: 7 days
7 days
The peak value of virus shedding from the nasal mucosa measured by viral culture
Time Frame: up to 9 days
up to 9 days
The time to peak of virus shedding from the nasal mucosa measured by viral culture
Time Frame: up to 9 days
up to 9 days
The duration of virus shedding from the nasal mucosa measured by viral culture
Time Frame: up to 9 days
up to 9 days
The daily incidence of virus shedding from the nasal mucosa measured by viral culture
Time Frame: up to 9 days
up to 9 days
The AUC of virus shedding from the nasal mucosa measured by qPCR
Time Frame: 6 days
6 days
The peak value of virus shedding from the nasal mucosa measured by qPCR
Time Frame: 6 days
6 days
The time to peak of virus shedding from the nasal mucosa measured by qPCR
Time Frame: 6 days
6 days
The duration of virus shedding from the nasal mucosa measured by qPCR
Time Frame: 6 days
6 days
The daily incidence of virus shedding from the nasal mucosa measured by qPCR
Time Frame: 6 days
6 days
Incidence of seroconversion to viral challenge strain
Time Frame: up to 28 days after viral challenge
up to 28 days after viral challenge
Incidence of seroprotection to viral challenge strain
Time Frame: up to 28 days after viral challenge
up to 28 days after viral challenge
Total tissue count and total mucus weight after viral inoculation
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theraclone Sciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eleanor L Ramos, MD, Theraclone Sciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCN-032-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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