Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
NCT05559905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2025-07-18
Summary
This is a 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 treatment with the drug MK-4482 (molnupiravir) will reduce the peak viral load (PVL) in the participant compared to placebo when given either before or after RSV-A Memphis 37b inoculation.
Conditions
Interventions
- DRUG
-
Molnupiravir
Four molnupiravir 200 mg capsules (800 mg total dose) taken twice daily by mouth.
- DRUG
-
Placebo capsule matched to molnupiravir taken twice daily by mouth.
- BIOLOGICAL
-
RSV A Memphis 37b
RSV A Memphis 37b viral challenge given once by intranasal administration at a dosage of \~4 Log10 plaque forming units (PFUs).
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-02
- Primary Completion
- 2023-04-18
- Completion
- 2023-06-08
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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