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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCN-032 | Experimental | single-dose, administered intravenously |
|
| Placebo (saline) | Placebo Comparator | single-dose, administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCN-032 | Biological |
| ||
| Placebo (saline) |
| Measure | Description | 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). | 7 days |
| Measure | Description | 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. | 7 days | |
| Pharmacokinetics (PK) and immunogenicity of TCN-032 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L. Mitcham | Contact | 206-805-1608 | jmitcham@theraclone-sciences.com | |
| Teri D. Koller | Contact | 206-805-1635 | tkoller@theraclone-sciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Eleanor L Ramos, MD | Theraclone Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25281755 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2014 | |
| Reset | Apr 25, 2014 | |
| Release | Apr 25, 2014 | |
| Reset | May 23, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2014 | Apr 25, 2014 | |||
| Apr 25, 2014 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| up to 28 days after viral challenge |
| Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28. | 28 days after viral challenge |
| Development of viral resistance to TCN-032 | 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. | up to 28 days after viral challenge |
| The duration of influenza symptoms or pyrexia | up to 10 days |
| The time to peak of influenza symptoms or pyrexia | up to 10 days |
| The daily incidence of influenza symptoms or pyrexia. | up to 10 days |
| The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia. | 7 days |
| The proportion of any grade influenza symptoms, or pyrexia | 7 days |
| The duration of any grade influenza symptoms, or pyrexia | 7 days |
| The time to peak of any grade influenza symptoms, or pyrexia | 7 days |
| The daily incidence of any grade influenza symptoms, or pyrexia | 7 days |
| The peak value of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The time to peak of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The duration of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The daily incidence of virus shedding from the nasal mucosa measured by viral culture | up to 9 days |
| The AUC of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The peak value of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The time to peak of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The duration of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| The daily incidence of virus shedding from the nasal mucosa measured by qPCR | 6 days |
| Incidence of seroconversion to viral challenge strain | up to 28 days after viral challenge |
| Incidence of seroprotection to viral challenge strain | up to 28 days after viral challenge |
| Total tissue count and total mucus weight after viral inoculation | 7 days |
| May 23, 2014 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |