A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16

NCT03338556 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PrEP-CS-003
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16

Conditions

Viral Upper Respiratory Tract Infection

Keywords

Rhinovirus; Healthy volunteer; Outpatient; Cold virus; HRV-16

Outcome Measures

Primary Outcomes (1)

• Total Symptom Scores

  Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities: Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache. Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)

  8 days

Secondary Outcomes (2)

• Area Under Curve of Symptom Scores

  8 days

• Incidence(s) of Laboratory Confirmed Illness

  8 days

Study Arms (4)

Cohort A - PrEP-001

ACTIVE COMPARATOR

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Drug: PrEP-001

Cohort A - Placebo

PLACEBO COMPARATOR

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0).

Other: Placebo

Cohort B- PrEP-001

ACTIVE COMPARATOR

PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Drug: PrEP-001

Cohort B - Placebo

PLACEBO COMPARATOR

Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0).

Other: Placebo

Interventions

PrEP-001 DRUG

Also known as: Poly-IC

Cohort A - PrEP-001; Cohort B- PrEP-001

Placebo OTHER

Cohort A - Placebo; Cohort B - Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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).
• 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 Investigator.

You may not qualify if:

• Subjects who have a significant history of any tobacco use at any time (total ≥10 pack year history \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\]).
• 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 cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, 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. The following conditions apply:
• Subjects with clinically mild atopic eczema/atopic dermatitis may be included at the Investigator's discretion (e.g., if there is no regular use of topical steroids, no eczema in cubital fossa)
• Subjects with any history of significant psychiatric illness should be excluded unless the illness resolved within 3 months, 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.
• Abnormal pulmonary function in the opinion of the Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry (forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)).
• Subjects with any history of COPD, pulmonary hypertension, asthma or chronic lung condition of any aetiology.
• A history of childhood asthma before the age of 12 years is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing (lasting less than 8 weeks) after age 12 years can be included at the Investigator's discretion provided the episode was more than 4 years ago and did not require a hospital admission and/or oral/intravenous steroids.
• Positive HIV, active hepatitis A (HAV), B (HBV), or C (HCV) test.
• Any significant abnormality altering the anatomy of the nose or nasopharynx.
• Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or a history of being hospitalized due to epistaxis on any previous occasion.

Sponsors & Collaborators

• Prep Biopharm Limited: lead
• Hvivo: collaborator

Study Sites (1)

hVIVO Services Limited, QMB Innovation Centre

London, E1 2AX, United Kingdom

Location

MeSH Terms

Interventions

Poly I-C

Intervention Hierarchy (Ancestors)

Poly C; Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Poly I

Results Point of Contact

• Title: Chief Medical Officer
• Organization: PrEP Biopharm Limited

info@prepbiopharm.com

8666207176

Study Officials

• Cyrus Ghobadi, MD

  hVIVO Services Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 9, 2017
• Study Start: April 6, 2016
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 9, 2018
• Results First Posted: June 27, 2018

Record last verified: 2018-11

Locations

GB (1)