NCT03198676

A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production

A Single Centre, Partially Blinded, Randomised Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production in Healthy Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Prep Biopharm Limited · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A safety study to compare the effect of two different formulations of PrEP-001 nasal powder when dosed in healthy subjects

Detailed description

A single centre, randomised, partially blinded placebo-controlled repeat dose study in healthy male subjects to compare the effect of two different formulations of PrEP-001 nasal powder on nasal mucosal and serum cytokine profiles when dosed for up to five days in health subjects and provide additional safety and tolerability information on active PrEP-001 nasal powder.

Conditions

• Upper Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	PrEP-001 6.4 mg	6.4 mg as 4 sprays per nostril (ie total of 8 sprays for a single dose) using Aptar unit dose strength powder (UDSP) device
DRUG	PrEP-001 6.4 mg	6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
DRUG	PrEP-001 3.2 mg	3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device
DRUG	Placebo	2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2017-06-26
• Last updated: 2017-07-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study