NCT03338556

A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16

A Phase IIa, Randomised, Double-blind, Placebo-controlled Outpatients Study to Investigate the Duration of Effect and Safety of PrEP-001 Given Prophylactically in Healthy Subjects, Subsequently Challenged With Human Rhinovirus (HRV-16)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Prep Biopharm Limited · Industry
• Sex: —
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Viral Upper Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	PrEP-001
OTHER	Placebo

Timeline

• Start date: 2016-04-06
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2017-11-09
• Last updated: 2018-11-09
• Results posted: 2018-06-27

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study