NCT06548854

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Grand Medical Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

One study evaluated the efficacy and safety of intravenous STC314 injection in patients with sepsis Sex and pharmacokinetic profiles of a multicenter, randomized, double-blind, placebo-controlled II Phase I dose exploration clinical trial

Detailed description

This is a randomized, double-blind, placebo-controlled phase II dose exploration study. The aim of this trial is to evaluate the efficacy, safety, and pharmacokinetic characteristics of STC314 injection in sepsis patients receiving loading dose and continuous intravenous infusion, determine the optimal therapeutic dose, and provide supporting evidence for phase III clinical trials. The overall design of the experiment is shown in Figure 1. This experiment consists of three parallel groups, including two treatment groups with different doses of STC314 injection and one placebo control group.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	STC314 Injection/STC314 Injection Placebo	All subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to receive continuous intravenous infusion of STC314 injection (dose in salt form) or placebo with continuous intravenous infusion of the same volume load infusion for 5 days at an overall ratio of 1:1:1.

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-11-30
• Completion: 2025-02-28
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

1 site across 1 country: China