Conditions: Influenza A H3N2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. arm 2: PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule. arm 3: Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

Interventions: intervention 1: PrEP-001 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: