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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

NCT06548854 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-08-12

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Grand Medical Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Gang Wu, PM · GrandPharma (China) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2024-11-30
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06548854 on ClinicalTrials.gov