Respiratory Syncytial Virus (RSV) Infections and Infestations
Conditions
Interventions
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group study in healthy adult male and female participants from 18 to 55 years of age, inclusive. The primary goal of thi
Sponsors
Shionogi BV
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Written study-specific informed consent signed and dated by the participant and the investigator obtained before any study-related assessment is performed. 2. Adult male or female aged between 18 and 55 years, inclusive, on the day prior to signing the study-specific ICF. 3. A total body weight =50 kg and body mass index (BMI) =18 kg/m² and =35 kg/m². 4. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), ECG, and routine laboratory tests as determined by the investigator. 5. Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening. 6. The following criteria apply to male and female participants: 6.1. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. 6.2. Male participants: - Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 90 days after the last dose of study intervention: - Refrain from donating fresh unwashed semen. - AND - Be abstinent from heterosexual intercourse and remain abstinent. - OR - Must agree to use contraception/barrier as detailed below. - Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception (see Appendix 5, Contraceptive and Barrier Guidance, Contraception Guidance) as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. - Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. 6.3. Female participants: - A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - She is a woman of nonchildbearing potential, as defined in Appendix 5, Contraceptive and Barrier Guidance, Definitions. - OR - Is a woman of childbearing potential and using a contraceptive method that is highly effective, with low user dependency, as described in Appendix 5, Contraception and Barrier Guidance, during the study intervention period and for at least 28 days after the last dose of study intervention. The PI/investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the initiation of study intervention. 7. Females of childbearing potential must have a negative serum pregnancy test prior to enrollment. 8. Serosuitable for the challenge agent.
Exclusion criteria
Exclusion criteria: 1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit. 2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematologic, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the Investigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply: 2.1. Participants with a history of resolved depression and/or anxiety may be included at the discretion of the PI. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may also be included at the PI’s discretion. As required, participants will be assessed prior to enrollment with a Patient Health Questionnaire (PHQ-9) and/or Generalized Anxiety Disorder Questionnaire (GAD-7) which must score less than or equal to 4 on admission. 2.2. Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI’s discretion. 2.3. Atopic dermatitis/eczema which is clinically severe and/or requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis/eczema, taking small amounts of regular dermal corticosteroids may be included at the PI’s discretion. 2.4. Any concurrent serious illness, including history of malignancy, that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion. 2.5. Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion. 2.6. Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI. 3. Any participants who have smoked =10 pack years at any time (10 pack years is equivalent to 1 pack of 20 cigarettes a day for 10 years). 4. Females who have been pregnant within 6 months prior to the study. 5. Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI. 6. Venous access denied inadequate for the phlebotomy and cannulation demands of the study. 7. 7.1. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded). 7.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral load of RSV-A Memphis 37-b infected participants will be determined using qRT-PCR on nasal wash samples from first dose of study drug until discharge. This will be measured twice daily from D2 until discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Viral load of RSV-A Memphis 37-b infected participants will be determined by using viral culture measurements on nasal wash samples to determine the maximum viral load from first dose of study drug until discharge. This will be measured twice daily from D2 until discharge. 2. Clinical symptom related scores in healthy adult participants infected with RSV through clinical symptom diary card administration (participant completed) from D-1 until Discharge, three times per day 3. Total amount of mucus produced through tissue number and weight from first dose of study drug until discharge | — |
Countries
England, United Kingdom
Contacts
Public ContactMadhuri;Calvin Patel;Chen
;
Outcome results
None listed