Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts

Summary

This phase 1 study was designed to evaluate the safety and tolerability of SZEY-2108 in single and multiple intravenous infusions, the pharmacokinetic profile of SZEY-2108 after single and multiple intravenous infusions, and the effect of exposure to SZEY-2108 after a single intravenous infusion on QT/QTc interval. Metabolites in each biological matrix (blood, urine, feces) and excretion characteristics (feces) after SZEY-2108 were analyzed.

Timeline

Start

2023-09-07

Primary completion

2024-05-31

Completion

2024-05-31

Outcome

Outcome not reported

Stopped: “Due to the termination criteria for dose escalation in the clinical protocol having been reached, this trial is terminated.”

Drugs

Indications