Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)

Summary

This is a phase 2a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of molnupiravir (MK-4482) in healthy participants inoculated with experimental influenza virus. The primary hypotheses are that MK-4482 initiated 12 hours following intranasal inoculation of the influenza challenge virus reduces the peak viral load compared to placebo and that MK-4482 initiated 2 days following intranasal inoculation of the influenza challenge virus reduces the viral load area under the curve (AUC) compared to placebo.

Timeline

Start

2023-08-21

Primary completion

2024-06-28

Completion

2024-06-28

Publications

• Schrell L, Scheibner D, Dickmanns A, Stegmann KM, Michaely LM, Graaf-Rau A, Beer P, Parker A, Diederich S, Balkema-Buschmann A, Dobbelstein M. Inhibitors of pyrimidine synthesis synergize with N4-hydroxycytidine to diminish influenza virus replication. Antiviral Res. 2025 Dec;244:106286. doi: 10.1016/j.antiviral.2025.106286. Epub 2025 Oct 3.

Drugs

Indications