InfluenzaPhase 2NCT01719874
Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza
A Phase 2 study testing TCN-032 in people with Influenza, run by Theraclone Sciences, Inc. at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TCN-032
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Influenza
- Being tested
- TCN-032, Placebo (saline)
- Keywords
- Influenza, monoclonal antibody
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCN-032Biological
Placebo (saline)Biological
| Study group | Role | What they receive |
|---|---|---|
| TCN-032 | Experimental | single-dose, administered intravenously Receives: Biological: TCN-032 |
| Placebo (saline) | Placebo comparator | single-dose, administered intravenously Receives: Biological: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days
Secondary outcomes (28)
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.
Measured: 7 days
Pharmacokinetics (PK) and immunogenicity of TCN-032
Measured: up to 28 days after viral challenge
Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.
Measured: 28 days after viral challenge
Development of viral resistance to TCN-032
Measured: 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.
Measured: up to 28 days after viral challenge
The duration of influenza symptoms or pyrexia
Measured: up to 10 days
The time to peak of influenza symptoms or pyrexia
Measured: up to 10 days
The daily incidence of influenza symptoms or pyrexia.
Measured: up to 10 days
The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Measured: 7 days
The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Measured: 7 days
The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Measured: 7 days
The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Measured: 7 days
The proportion of any grade influenza symptoms, or pyrexia
Measured: 7 days
The duration of any grade influenza symptoms, or pyrexia
Measured: 7 days
The time to peak of any grade influenza symptoms, or pyrexia
Measured: 7 days
The daily incidence of any grade influenza symptoms, or pyrexia
Measured: 7 days
The peak value of virus shedding from the nasal mucosa measured by viral culture
Measured: up to 9 days
The time to peak of virus shedding from the nasal mucosa measured by viral culture
Measured: up to 9 days
The duration of virus shedding from the nasal mucosa measured by viral culture
Measured: up to 9 days
The daily incidence of virus shedding from the nasal mucosa measured by viral culture
Measured: up to 9 days
The AUC of virus shedding from the nasal mucosa measured by qPCR
Measured: 6 days
The peak value of virus shedding from the nasal mucosa measured by qPCR
Measured: 6 days
The time to peak of virus shedding from the nasal mucosa measured by qPCR
Measured: 6 days
The duration of virus shedding from the nasal mucosa measured by qPCR
Measured: 6 days
The daily incidence of virus shedding from the nasal mucosa measured by qPCR
Measured: 6 days
Incidence of seroconversion to viral challenge strain
Measured: up to 28 days after viral challenge
Incidence of seroprotection to viral challenge strain
Measured: up to 28 days after viral challenge
Total tissue count and total mucus weight after viral inoculation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theraclone Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleanor L Ramos, MD, Study director, Theraclone Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719874
- Sponsor's protocol ID
- TCN-032-002
- Status last verified
- Oct 2012
- First submitted
- 25 Oct 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramos EL, Mitcham JL, Koller TD, Bonavia A, Usner DW, Balaratnam G, Fredlund P, Swiderek KM. Efficacy and safety of treatment with an anti-m2e monoclonal antibody in experimental human influenza. J Infect Dis. 2015 Apr 1;211(7):1038-44. doi: 10.1093/infdis/jiu539. Epub 2014 Oct 3.
PubMed 25281755
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01719874
- Acronym / sponsor ID
- TCN-032-002
- Conditions
- Influenza
- Keywords
- Influenza, monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Theraclone Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCN-032 | Experimental | Biological: TCN-032single-dose, administered intravenously |
| Placebo (saline) | Placebo comparator | Biological: Placebo (saline)single-dose, administered intravenously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCN-032 | Biological | TCN-032 |
| Placebo (saline) | Biological | Placebo (saline) |
Primary outcome
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
28 secondary outcomes
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
Pharmacokinetics (PK) and immunogenicity of TCN-032
Time frame: 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
Development of viral resistance to TCN-032
Time frame: 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
The duration of influenza symptoms or pyrexia
Time frame: up to 10 days
The time to peak of influenza symptoms or pyrexia
Time frame: up to 10 days
The daily incidence of influenza symptoms or pyrexia.
Time frame: 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
The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time frame: 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
The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
Time frame: 7 days
The proportion of any grade influenza symptoms, or pyrexia
Time frame: 7 days
The duration of any grade influenza symptoms, or pyrexia
Time frame: 7 days
The time to peak of any grade influenza symptoms, or pyrexia
Time frame: 7 days
The daily incidence of any grade influenza symptoms, or pyrexia
Time frame: 7 days
The peak value of virus shedding from the nasal mucosa measured by viral culture
Time frame: 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
The duration of virus shedding from the nasal mucosa measured by viral culture
Time frame: up to 9 days
The daily incidence of virus shedding from the nasal mucosa measured by viral culture
Time frame: up to 9 days
The AUC of virus shedding from the nasal mucosa measured by qPCR
Time frame: 6 days
The peak value of virus shedding from the nasal mucosa measured by qPCR
Time frame: 6 days
The time to peak of virus shedding from the nasal mucosa measured by qPCR
Time frame: 6 days
The duration of virus shedding from the nasal mucosa measured by qPCR
Time frame: 6 days
The daily incidence of virus shedding from the nasal mucosa measured by qPCR
Time frame: 6 days
Incidence of seroconversion to viral challenge strain
Time frame: up to 28 days after viral challenge
Incidence of seroprotection to viral challenge strain
Time frame: up to 28 days after viral challenge
Total tissue count and total mucus weight after viral inoculation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Derived from this study: PubMed 25281755Ramos EL, Mitcham JL, Koller TD, Bonavia A, Usner DW, Balaratnam G, Fredlund P, Swiderek KM. Efficacy and safety of treatment with an anti-m2e monoclonal antibody in experimental human influenza. J Infect Dis. 2015 Apr 1;211(7):1038-44. doi: 10.1093/infdis/jiu539. Epub 2014 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor L Ramos, MD study director
Theraclone Sciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCN-032 in people with Influenza, run by Theraclone Sciences, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L. Mitcham (206-805-1608, jmitcham@theraclone-sciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.