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

Study results available
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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

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559905 on ClinicalTrials.gov