A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

Study Overview
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Brief Summary
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The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/RV521) for the potential treatment of respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the treatment period. RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant. This study is seeking healthy participants who are: Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts of 33 participants each. In both cohorts participants will be exposed to the challenge virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. Participants will start taking the study medicine upon confirmation of RSV infection (or evening of Day 5 if not positive to RSV). The study medicine will be administered 12 hours apart (or twice daily). Each participant will remain in the quarantine unit until discharge on Day 12.

Official Title
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A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Antiviral Activity Of Multiple Doses Of RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: RV521
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 45 years, inclusive In good health with no history of major medical conditions A total body weight ≥ 50 kg and a body mass index (BMI) of >/=18kg/m2 and </=30kg/m2 Exclusion Criteria: Evidence of any clinically significant or currently active major medical condition Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test Significant nose or nasopharynx abnormalities Abnormal lung function History or currently active symptoms suggestive of upper or lower respiratory tract infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RV521<br>RV521 drug substance in capsule for oral administration | Drug: RV521<br>* RV521 drug in capsules<br>|
| Placebo Comparator: Placebo<br>Micro-crystalline cellulose in capsule for oral administration | Drug: Placebo<br>* Placebo in capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load |  | Baseline to study day 12 |