A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged with Human Rhinovirus (HRV-16 [hVIVO])

hVIVO Services Limited0 sites40 target enrollmentOctober 8, 2015

ConditionsHuman Rhinovirus (HRV-16)MedDRA version: 18.0 Level: PT Classification code 10075163 Term: Human rhinovirus test System Organ Class: 10022891 - Investigations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Rhinovirus (HRV-16)
Sponsor: hVIVO Services Limited
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 8, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

hVIVO Services Limited

Eligibility Criteria

Inclusion Criteria

•Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (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\.
•A pre\-bronchodilator FEV1 \= 60% of predicted subject’s normal value at the first screening, on admission to quarantine, and prior to dosing on Day \-2\.
•In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
•A total body weight \= 50 kg and Body Mass Index (BMI) \= 18 kg/m2\. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
•The following inclusion criteria are applicable to subjects in a heterosexual relationship (i.e., the criteria do not apply to those in a same sex relationship):
•\- True abstinence \- when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post\-ovulation methods] and withdrawal are not acceptable methods of contraception).
•Female study subjects who are not heterosexually active must have periodic confirmation of continued abstinence from heterosexual intercourse
•\- Two forms of effective contraceptive methods among (between) the couple, which are defined as:
•i. Condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post\-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study).

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.
•Females who: • Are breastfeeding, or • Have been pregnant within 6 months prior to the study, or • Have a positive pregnancy test at any point during screening or prior to first dosing with IMP.
•Any history or evidence of any clinically significant medical and psychiatric conditions (as defined in section 5\.4 of the study protocol).
•History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of atopic eczema/atopic dermatitis as described in exclusion criteria number 5 of the protocol.
•Exacerbation of asthma symptoms within 1 month prior to Screening and Day \-4 and requiring the use of oral steroids, antibiotics, Accident and Emergency visit, or hospital admission.
•Positive HIV, active hepatitis A virus (HAV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV) test.
•Any significant abnormality altering the anatomy of the nose or nasopharynx (including significant nasal polyps).
•Any clinically significant history of epistaxis (nosebleeds) within the last 12 months AND/OR • History of being hospitalized due to epistaxis on any previous occasion.
•Any nasal or sinus surgery within 6 months of Viral Challenge.