Conditions: Viral Upper Respiratory Tract Infection
Keywords: Rhinovirus Healthy volunteer Outpatient Cold virus HRV-16
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: yes

Brief summary:
A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16

Detailed description:
A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects, subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to placebo at two different dosing regimens

Arms:
arm 1: PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). arm 2: Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). arm 3: PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). arm 4: Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

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

Protocol document: