Merck Sharp & Dohme LLC
This is a phase 2A, double-blind, randomized, placebo-controlled study of molnupiravir (MK-4482) in healthy participants who have been inoculated with an experimental Respiratory Syncytial Virus (RSV) [RSV-A Memphis 37b]. It is hypothesized that MK-4482 will reduce the peak viral load (PVL) compared to placebo when given either before (prophylactic) or after (treatment) RSV-A Memphis 37b inoculation. Participants arrive at the study center for check-in between Day -3 and Day -1. The assigned treatment sequence (consisting of a combination of molnupiravir or placebo) begins Day -1. Participants receive viral inoculation with RSV-A Memphis 37b on Day 0, and depart on Day 12. There is a follow-up visit on Day 28.
Respiratory Syncytial Virus
Molnupiravir
Placebo
RSV A Memphis 37b
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 116 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-4482 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus |
Actual Study Start Date : | November 2, 2022 |
Estimated Primary Completion Date : | April 18, 2023 |
Estimated Study Completion Date : | June 8, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Panel A: Molnupiravir Prophylaxis Participants receive molnupiravir 800 mg every 12 hours for 5 days beginning on Day -1, and are inoculated with RSV-A Memphis 37b on Day 0. Participants then receive placebo on the evening of Day 4 to the morning of Day 10. |
Drug: Molnupiravir Drug: Placebo |
Experimental: Panel B: Molnupiravir Triggered Treatment Participants receive placebo on Day -1, are inoculated with RSV-A Memphis 37b on Day 0, and continue to receive placebo until testing positive for RSV. Participants then receive molnupiravir 800 mg every 12 hours for 5 days. |
Biological: RSV A Memphis 37b Drug: Molnupiravir |
Placebo Comparator: Panel C: Matched Placebo Participants receive placebo from Day -1 to Day 10, and are inoculated with RSV-A Memphis 37b on Day 0. |
Drug: Placebo Biological: RSV A Memphis 37b |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
hVIVO Services ( Site 0001)
London, London, City Of, United Kingdom, E1 2AX