Study Examining PrEP-001 in Subjects With Asthma

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvivo
• Collaborator: Prep Biopharm Limited

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