Influenza A H3N2 Clinical Trial
Official title:
A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged With Influenza A/Perth/16/2009 (H3N2) Virus
Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
Screening took place up to 90 days before quarantine. Volunteers completed an informed
consent and underwent screening assessments to determine their eligibility.
There were 2 study groups:
Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with
Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to
attend Quarantine on Day -2 or -1.
Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to
placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on
Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.
Volunteers remained in quarantine unit for 8 days after inoculation.
At day 28, end of study visit, volunteers seen and assessed by a study physician for
well-being, on-going symptoms and adverse events.
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