A Phase 2 interventional study of TCN-032 and Placebo (saline) in Influenza, sponsored by Theraclone Sciences, Inc.. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-01.
Sponsored by Theraclone Sciences, Inc. · Phase 2, Interventional, and Treatment
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 64 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Theraclone Sciences, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single-dose, administered intravenously
Biological: TCN-032
single-dose, administered intravenously
Biological: Placebo (saline)
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
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
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Theraclone Sciences, Inc.