The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01 in Phase I.

Summary

The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary efficacy of injectable SPN01 in subjects with colorectal cancer. (2) to evaluate the effect of the blood concentration of injectable SPN01 on the QTc interval. (3) to evaluate the metabolic characteristics of injectable SPN01 in humans.

Timeline

Start

2024-12-17

Primary completion

2026-04-10

Completion

2026-04-10

Drugs

Indications