Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects

Summary

This study will examine the use of a single infusion of S315 at different doses in healthy volunteers to help understand its safety and tolerability. S315 is a monoclonal antibody that is being developed for treatment of diphtheria. The study will assess for any side effects when S315 and will also look at the levels of S315 in the blood over time.

Timeline

Start

2019-04-23

Primary completion

2019-10-07

Completion

2019-10-07

Publications

• Background Smith HL, Cheslock P, Leney M, Barton B, Molrine DC. Potency of a human monoclonal antibody to diphtheria toxin relative to equine diphtheria anti-toxin in a guinea pig intoxication model. Virulence. 2016 Aug 17;7(6):660-8. doi: 10.1080/21505594.2016.1171436. Epub 2016 Apr 12.
• Sullivan-Bolyai JZ, Allen LB, Cannon R, Cohane KP, Dunzo E, Goldwater R, StCyr K, Wang Y, Klempner MS. A Phase 1 Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (S315) Against Diphtheria Toxin. J Infect Dis. 2025 Sep 15;232(3):534-539. doi: 10.1093/infdis/jiae499.

Drugs

Indications