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

NCT03198676 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-02

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Prep Biopharm Limited

    lead INDUSTRY

Principal Investigators

  • Litza McKenzie, MBChB BSc · Quotient Clinical

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2017-05-24
Completion
2017-05-24
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198676 on ClinicalTrials.gov