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Study Examining PrEP-001 in Subjects With Asthma

NCT03296917 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-09-29

No results posted yet for this study

Summary

Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses of the study drug/placebo.

Conditions

Interventions

DRUG

PrEP-001

A spray dried powder for intranasal administration formulated from an aqueous mixture of pre-gelatinized waxy maize starch and the drug substance delivered using a single dose nasal powder device.

DRUG

G-004

A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device

Sponsors & Collaborators

  • Prep Biopharm Limited

    collaborator INDUSTRY

  • Hvivo

    lead INDUSTRY

Principal Investigators

  • John Efthimiou · Sponsor's Representative

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2016-09-30
Completion
2016-09-30

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Entities

Diseases

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 NCT03296917 on ClinicalTrials.gov