A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study

Summary

This randomized, double-blind, placebo-controlled, 4 part study will assess the safety, tolerability, pharmacokinetics and antiviral activity of orally administered AL-794 in healthy volunteers (HV).

Timeline

Start

2015-08-31

Primary completion

2017-08-14

Completion

2017-08-14

Publications

• Yogaratnam J, Rito J, Kakuda TN, Fennema H, Gupta K, Jekle CA, Mitchell T, Boyce M, Sahgal O, Balaratnam G, Chanda S, Van Remoortere P, Symons JA, Fry J. Antiviral Activity, Safety, and Pharmacokinetics of AL-794, a Novel Oral Influenza Endonuclease Inhibitor: Results of an Influenza Human Challenge Study. J Infect Dis. 2019 Jan 7;219(2):177-185. doi: 10.1093/infdis/jiy410.
• Kakuda TN, Yogaratnam J, Rito J, Boyce M, Mitchell T, Gupta K, Symons JA, Chanda S, Van Remoortere P, Fry J. Phase I study on safety and pharmacokinetics of a novel influenza endonuclease inhibitor, AL-794 (JNJ-64155806), following single- and multiple-ascending doses in healthy adults. Antivir Ther. 2018;23(7):555-566. doi: 10.3851/IMP3244. Epub 2018 Jun 21.

Drugs

Indications