RSV Infection MedDRA version: 20.0 Level: HLT Classification code 10038717 Term: Respiratory syncytial viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: MDT-637
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Not available
CAS Number: 235106-62-4
Current Sponsor
Sponsors
MicroDose Therapeutx, Inc., a wholly owned subsidiary of Teva Pharmaceuticals Industries, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 45 years, inclusive. 2. In good health with no history of major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator by a screening evaluation. 3. A Total body weight =50kg and a BMI >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female). 4. (a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 28 follow-up visit. (b) In addition, male subjects must not donate sperm following discharge from Quarantine until the Day 28 follow-up visit. (c) Female subjects must be either: - post-menopausal (defined as at least one year documented history without any menses/or post-menopausal females (confirmed by FSH test) prior to Screening or - documented status as surgically sterile or post hysterectomy or - if of childbearing potential, must have a negative urine pregnancy test at SSS and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 28 follow-up visit. Acceptable forms of effective contraception include: - Established use of oral, injected or implanted hormonal methods of contraception - Placement of an intrauterine device (IUD) or intrauterine system (IUS). - Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. - Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject]. 5. An informed consent document voluntarily signed and dated by the subject and investigator 6. Sero-suitable for Challenge Virus Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Subjects who have a significant history of any tobacco use at any time (= total 10 pack year history) 2. Subjects who are pregnant or breast feeding; or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period 3. Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the medical investigator. Eczema/Atopic Dermatitis: subjects with clinically mild eczema/atopic dermatitis may be included at the Investigator's discretion. Psoriasis: patients with active psoriasis affecting less than 5% of the body's surface area for the past five years can be included at the Investigator's discretion. Patients with a history of completely resolved guttate psoriasis can be included. Subjects with a diagnosis of a single mild or moderate depressive episode two or more years ago, with good evidence of preceding stressors and which resolved within approximately three months, may be included at the Investigator's discretion. 4. Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities in spirometry. 5. History or evidence of autoimmune disease or known immunodeficiency of any cause. 6. Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology. 7. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion provided the episode is more than four years ago and did not require a hospital admission and/or oral steroids. 8. Positive HIV, hepatitis B , or hepatitis C test. 9. Any significant abnormality altering the anatomy of the nose or nasopharynx. 10. Any clinically significant history of epistaxis. 11. Any nasal or sinus surgery within 6 months of inoculation. 12. Recurrent history of clinically significant autonomic dysfunction. 13. Any laboratory test or ECG, which is abnormal and deemed by the investigator(s) to be clinically significant. 14. Confirmed positive test for cotinine and /or drugs of abuse deemed by the Investigator to be clinically significant. 15. Unable to comply with study procedures including venous access deemed inadequate for the phlebotomy and cannulation demands of the study. 16. Any known allergies to the excipients in the Challenge Virus inoculum or investigational product. Specifically severe lactose intolerance. 17. Health care workers who work in units with severely immuno-compromised patients. 18. Presence of household member or close contact (for an additional two weeks after discharge from the isolation facility) who: has known immunodeficiency is receiving immunosuppressant medication is undergoing or soon to undergo cancer che
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective and endpoint of the study is to evaluate the antiviral effect (as defined by reduction in AUC of viral load) of aerosolized MDT-637, in a manner which mimics the timing of the infection and potential treatment application in infants and children. ; Secondary Objective: The secondary efficacy objectives include: ? - Virology o Antiviral effect (as defined by reduction in log AUC viral load by TCID50) o Duration and peak of virus shedding ? - Clinical o The reduction in nasal mucous production o The reduction in symptom scores ? - Device o Performance of the EPIC Inhaler The safety objectives are: ? - To evaluate the safety profile of MDT-637 in the RSV-A (Memphis 37b) infected human respiratory tract. ? - To determine the safety of the inhaler device The exploratory objectives are: ? - To investigate the potential for the development of viral resistance. ? - To determine the quality of sleep ; Primary end point(s): The primary endpoint of the study is to evaluate the antiviral effect (as defined by reduction in AUC of viral load) of aerosolized MDT-637, in a manner which mimics the timing of the infection and potential treatment application in infants and children. This will be measured by analysing the area under the curve (AUC) for each subject via Quantitative Polymerase Chain Reaction Viral Load. ; Timepoint(s) of evaluation of this end point: Frequency and method: The Viral load will be detected and quantified in using aliquots from the nasal wash samples taken twice a day from Quarantine Day 1 post inoculum through to Day 12. The samples will be processed by Retroscreen Labora | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy objectives include: - Virology o Antiviral effect (as defined by reduction in log AUC viral load by TCID50) o Duration and peak of virus shedding - Clinical o The reduction in nasal mucous production o The reduction in symptom scores - Device o Performance of the EPIC Inhaler ; Timepoint(s) of evaluation of this end point: Virology: The Time point of evaluation of this end points will be evaluated by Nasal wash for Virology and Virus shedding twice daily on Day 1 to day 12 Post-Inoculation. The time point for evaluation using viral serology is Day -2 and Day 28. Clinical: The Time point of evaluation of Nasal mucous production is Once daily on Day 1 to Day 12 post-Inoculation. The Time point of Symptom scores is Four times daily on Day 1 to Day 12 Post-Inoculation. | — |
Countries
United Kingdom
Contacts
Public ContactRobert Cook, Ph.D MRPharmS
MicroDose Therapeutx, Inc.
Outcome results
None listed