NCT06710561

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

The Phase I Single-center, Single-blind, Randomized Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Beijing SonoPhotoNano Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	SPN01 for Injection	After each subject was randomly assigned, different doses of SPN01 for Injection (0.02 mg/kg, 0.06 mg/kg, 0.12 mg/kg) were administered intravenously in a single dose.
OTHER	Placebo	After each subject was randomly assigned, a single intravenous injection of 0.9% sodium chloride was administered
DRUG	SPN01 for Injection	Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose.

Timeline

• Start date: 2024-12-17
• Primary completion: 2026-04-10
• Completion: 2026-04-10
• First posted: 2024-11-29
• Last updated: 2024-12-03