An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge

Summary

The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a placebo with respect to its antiviral activity in healthy adult participants inoculated with Dengue Serotype 3.

Timeline

Start

2022-02-03

Primary completion

2023-05-16

Completion

2024-09-10

Outcome

Met primary endpoint

paper High-dose mosnodenvir led to a significantly lower DENV-3 RNA load, assessed as the log10 AUCD1-29, than placebo (two-sided P<0.001 by tobit analysis of variance). PMID 41297006 ↗

Publications

• Durbin AP, Van Wesenbeeck L, Pierce KK, Herrera-Taracena G, Ebone L, Buelens A, Lutton P, Sabundayo BP, Van Eygen V, De Clerck K, Fetter I, Voge NV, Fang X, Goeyvaerts N, Vandendijck Y, Mayfield J, Lenz O, De Meyer S, Kakuda TN, He H, Amaro-Carambot E, Akli RD, Carmolli M, De Marez T, Whitehead SS, Van Loock M, Rasschaert F. Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model. N Engl J Med. 2025 Nov 27;393(21):2107-2118. doi: 10.1056/NEJMoa2500179.

Drugs

Indications