Status:
COMPLETED
Study Examining PrEP-001 in Subjects With Asthma
Lead Sponsor:
Hvivo
Collaborating Sponsors:
Prep Biopharm Limited
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 d...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03296917
Start Date
December 11 2015
End Date
September 1 2016
Last Update
September 29 2017
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