Outpatient Study - Prophylactic Administration of PrEP-001 Against HRV

• Research type

  Research Study

• Full title

  A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to investigate the duration of effect and evaluate further safety of PrEP-001 given prophylactically in healthy subjects, subsequently challenged with human rhinovirus (HRV-16)

• IRAS ID

  198417

• Contact name

  Cyrus Ghobadi

• Contact email

  c.ghobadi@hvivo.com

• Sponsor organisation

  PrEP Biopharm

• Eudract number

  2015-005492-25

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  This will be a human Viral Challenge study in which healthy subjects will receive a once-daily nasal dose of either PrEP-001 or placebo for 2 consecutive days. This will then be followed several days later by an intranasal Viral Challenge with HRV-16; the timing of dosing relating to the viral challenge is dependent upon the cohort in which the subject is enrolled. The safety and tolerability, antiviral effect and effect on HRV signs and symptoms following dosing with PrEP-001 will be assessed.
  The study will be conducted by hVIVO Services Limited, which has extensive experience with HRV challenge studies. To date, in hVIVO’s studies, ~600 subjects have been successfully and safely inoculated with HRV-16.
  Administration of study drug and challenge with HRV will take place in hVIVO’s specialised unit. The study procedures (including collection of blood, urine, and nasopharyngeal secretions for assessment of safety and efficacy) have been employed in previous studies conducted by hVIVO.
  Studies HRV have demonstrated that adults could be infected by nasal inoculation and that experimental infection was safe. This strain has been shown to cause symptoms and virus shedding that closely match natural infection, but with a safety record in animals that has not shown any particular virulence that might endanger subjects.
  

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  16/WM/0030

• Date of REC Opinion

  10 Mar 2016

• REC opinion

  Further Information Favourable Opinion