Human Rhinovirus (HRV-16) MedDRA version: 19.0 Level: PT Classification code 10075163 Term: Human rhinovirus test System Organ Class: 10022891 - Investigations
Conditions
Sponsors
PrEP Biopharm Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP) 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 who are in a heterosexual relationship and female subjects in a female same sex relationship (i.e. the criteria do not apply to those in a male same sex relationship): a) 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). Or b) Two forms of effective contraceptive methods among (between) the couple, which are defined as: • For males: 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). • For females: i. Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for at least 2 years, otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to female subjects participating in the study). ii. If of childbearing potential, then acceptable forms of contraception include: o Established (a minimum of 2 weeks prior to first dosing with IMP) use of oral, injected or implanted hormonal methods of contraception. - Placement of an intrauterine device (IUD) or intrauterine system (IUS). - Barrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following - spermicidal foam/gel/film/cream/suppository. • The longevity of contraception is as follows: i. Male subjects must comply with agreed contraception from the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later. ii. Male subjects must not donate sperm following the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later. iii. Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of first dosing with IMP and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from at least 14 days prior to the first IMP dosing and continuing until 90 days after the date of the last IMP dosing or Viral Challenge whichever happens later. An informed consent document signed and dated by the subject and the Investigat
Exclusion criteria
Exclusion criteria: Subjects who have a significant history of any tobacco use at any time Females who are breastfeeding or pregnancy 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 cardiovascular, dermatological gastrointestinal, endocrine, haematological, hepatic, immunological, metabolic, urological, neurological, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study is exclusionary •Subjects with clinically mild atopic eczema/atopic dermatitis may be included at the Investigator's discretion Subjects with a diagnosis of mild or moderate depressive episode(s) which occurred 2 or more years ago, with good evidence of preceding stressors and which resolved within approximately 3 months may be included in the Investigator's opinion During screening, if subjects have a total cholesterol level > 6mmol/l they will be excluded from the study. Any concurrent serious illness may interfere with a subject completing the study Abnormal pulmonary function in opinion of Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry A history or evidence of an autoimmune disease or known immunodeficiency Subjects with any history of COPD, pulmonary hypertension, asthma or chronic lung condition of any aetiology History childhood asthma before the age of 12 years is acceptable provided subject is asymptomatic without treatment. Subjects with single episode of wheezing (lasting less than 8 weeks) after age 12 can be included at Investigator's discretion provided episode was more than 4 yrs ago not requiring hospital admission and/or oral/intravenous steroids Positive HIV, active hepatitis A, B or C test Significant abnormality altering anatomy of nose/nasopharynx Clinically significant history of epistaxis within last 12 months Nasal/sinus surgery within 6 months of first dosing Recurrent history of fainting Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by Investigator Confirmed positive test for drugs of abuse deemed by Investigator as clinically significant Venous access deemed inadequate for phlebotomy and cannulation demands of study Clinically significant allergies such as allergy to the excipients in the Challenge Virus inoculum stipulated in protocol Evidence of vaccinations within 4 weeks prior to planned date of first dosing with IMP or intention to receive any vaccination(s) before last day of study Those employed, or immediate relatives of those employed, at hVIVO or Sponsor Receipt of blood or blood products, or loss of 450 mL or more of blood during 3 months prior to the planned date of first dosing with IMP or planned during the 3 months after the final visit Use within 7 days prior to the planned date of first dosing with IMP of any medication or product, for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects, subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to placebo at two different dosing regimens; Secondary Objective: To determine the prophylactic effect of PrEP-001 after repeated nasal dosing in healthy subjects subsequently challenged with HRV-16, on clinical signs and symptoms and rates of clinical illness To determine the safety and tolerability of PrEP-001 after repeated nasal dosing in healthy subjects subsequently challenged with HRV-16 ;Primary end point(s): Overall total symptom score, defined as the sum of the total symptom scores from day 1 to day 8, inclusive, using the 10-point symptom diary card.;Timepoint(s) of evaluation of this end point: Up to Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The area under the curve (AUC) of symptom scores , using symptoms from day 1 to day 8 from the 10-point symptom diary card, calculated separately for total symptoms, upper respiratory tract, lower respiratory tract and systemic viral symptoms • Overall symptom score, defined as the sum of the symptom scores from day 1 to day 8, inclusive, using the 10-point symptom diary card, calculated separately for upper respiratory tract, lower respiratory tract and systemic viral symptoms • Duration of symptoms • Peak symptom score • Time to peak symptom • Time to resolution from peak symptoms Incidence(s) of illness and infection: • Laboratory confirmed HRV-16 infection (as defined by a positive result in a quantitative polymerase chain reaction (qPCR) assay from the combined nasal washes of days 3, 4 and 5) • HRV-like illness • Sub-clinical infection • Upper respiratory tract illness • Lower respiratory tract illness • Febrile illness • Systemic illness • Asymptomatic and uninfected Secondary safety endpoints: • AEs/SAEs • Vital signs • Biochemistry/haematology and coagulation • ECGs • Spirometry ;Timepoint(s) of evaluation of this end point: Up to Day 10 (+/- 2 Days) | — |
Countries
United Kingdom
Contacts
Public ContactRegulatory Affairs
hVIVO Services Limited
Outcome results
None listed