Phase 2a Study to Test TCN-032 in Volunteers Challenged with Influenza

• Research type

  Research Study

• Full title

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

• IRAS ID

  104113

• Contact name

  Ganesh Balaratnam

• Sponsor organisation

  Theraclone Sciences, Inc

• Eudract number

  2012-000854-73

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Phase 2a, randomized double-blinded, study to evaluate the effect of study drug - TCN-032 compared to placebo (dummy) on the development of clinical flunza symptoms and total virus shedding from the nasal mucosa of healthy volunteers. Up to 64 volunteers will be inoculated or 'challenged' with flunza virus and then dosed with TCN-032 or placebo. Volunteers will be screened to identify up to 64 suitable volunteers to participate in the study. At the study specific screening visit volunteers will provide informed consent and undergo the scheduled screening assessments which will include a blood test to assess the presence of antibodies to the flunza virus. If the volunteers fulfill all the eligibility criteria they will be asked to attend the Quarantine unit on Day -2 (Day -1) prior to challenge. Eligible volunteers will be challenged with the flunza virus strain, flunza A/Wisconsin/67/2005 (H3N2) on Day 0. Volunteers will then be randomized (1:1) to either TCN-032 or placebo treatment in a blinded fashion. Approximately 24 hours (Day 1) after virus challenge, the randomized volunteers will receive a single dose of study drug, via intravenous (IV) infusion over a 2-hour period. On Day 7, a 5-day course of a licensed flunza antiviral medication will be started. Volunteers will be required to stay in quarantine for a total of 11-13 days. Following discharge from quarantine, volunteers will attend a follow-up visit, at approximately 28 days after exposure to the study flunza virus. A subset of approximately 12 volunteers, who are providing pharmacokinetics (PK) and anti-drug antibody (ADA) blood samples will return to the Retroscreen clinic for a follow-up on Day 15.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0838

• Date of REC Opinion

  21 Jun 2012

• REC opinion

  Favourable Opinion