A Phase I Study to Investigate KH-001 in Healthy Males

This was a Phase I, first-in-human study of KH-001 besylate in healthy male participants, conducted to investigate the safety, tolerability and pharmacokinetics (PK) of the study drug. The study was conducted in three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part, and a Formulation Effect part evaluating an orodispersible tablet (ODT) formulation. The study also evaluated the effect of KH-001 besylate on suicidality risk and mood. KH-001 besylate is being developed as an on-demand oral treatment for premature ejaculation.