Study Examining PrEP-001 in Subjects With Asthma

NCT ID: NCT03296917

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-11
• Study Completion Date: 2016-09-30

Brief 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.

Detailed Description

Screening took place up to 90 days before quarantine, where volunteers were asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.

Eligible volunteers were invited to test and record their respiratory symptoms and peak expiratory flow (PEF), medications and any adverse events in diary cards from Day -14 to Day -5.

They attended Quarantine on Day -4/-3, received the study drug/placebo intra nasally on Day -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study drug/placebo was 1:1.

Volunteers remained in the quarantine unit for 8 days after inoculation.

PEF self-testing continued from Day 9 to Day 28.

On Day 20 (±3 days) and Day 28 (±5 days), volunteers attended follow up visits where they were assessed by a study physician for well-being, on-going symptoms and adverse events.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

IMP - PrEP-001

In Viral Challenge arm cohort:

A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).

In the Safety arm's first dose cohort:

A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).

Then assuming no significant safety issues with the lower dose (as determined by blinded review by the DSMB team), the Safety arm's second dose cohort will consist of:

A nasal dose of 12800 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1)

Group Type: EXPERIMENTAL

PrEP-001

Intervention Type: DRUG

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.

Placebo - G-004

In the Viral Challenge arm and each Safety Arm cohort:

A nasal dose of placebo equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).

Group Type: PLACEBO_COMPARATOR

G-004

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

G-004

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 55 years on the day of first dosing with IMP.
• Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
• In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.

Exclusion Criteria

• Any ex-smoker or smoker with a history of more than 10 pack-years.
• History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
• Any history or evidence of any clinically significant medical and psychiatric conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prep Biopharm Limited

INDUSTRY

Sponsor Role: collaborator

Hvivo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Efthimiou

Role: STUDY_CHAIR

Sponsor's Representative

Other Identifiers

PrEP-CS-002

Identifier Type: -

Identifier Source: org_study_id