NCT03198676View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 8, 2017

Primary Completion Date

May 24, 2017

Study Completion Date

May 24, 2017

Conditions
Upper Respiratory Tract Infections
Interventions
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

Trial Locations (1)

NG11 6JS

Quotient Clinical, Nottingham

All Listed Sponsors
lead

Prep Biopharm Limited

INDUSTRY

NCT03198676 - A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production | Biotech Hunter | Biotech Hunter