STC3141 / China Grand Pharma - LARVOL DELTA

A dose-adjusted, open-label, pilot study of the safety, tolerability, and pharmacokinetics of STC3141 in critically ill patients with sepsis. (PubMed, Pharmacol Res Perspect) - "STC3141 administration appeared to have an acceptable degree of safety and tolerability and expected pharmacokinetics. Cautious, larger randomized efficacy trials in sepsis appear justified."

Journal • PK/PD data • Hematological Disorders • Infectious Disease • Inflammation • Septic Shock

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 (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Grand Medical Pty Ltd.

New P2 trial • Infectious Disease • Septic Shock

STC3141 improves acute lung injury through neutralizing circulating histone in rat with experimentally-induced acute respiratory distress syndrome. (PubMed, Front Pharmacol) - "All animals survived. Neutralization of histone using STC3141, especially at high dose, had similar therapeutic effects to dexamethasone in this LPS double-hit rat ALI model, with significantly decreased circulating histone concentration, improved acute lung injury and oxygenation."

Journal • Preclinical • Acute Lung Injury • Acute Respiratory Distress Syndrome • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019（COVID-19）Pneumonia (clinicaltrials.gov) - P2a | N=25 | Completed | Sponsor: Grand Medical Pty Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • CRP

Neutralization circulation histone with sodium-β-o-methyl cellobioside sulphate in sepsis (a prospective randomized double-blinded placebo-controlled preclinical trial) (ISICEM 2022) - "Our hypothesis was that the neutralization of histones with Sodium-β-O-Methyl cellobioside sulphate (STC3141, from Grandpharma, China) in sepsis might improve sepsis outcome... Neutralization histone with STC3141in sepsis quickly stabilized hemodynamics with less NE utilization, ameliorated impaired microcirculation and improved tissue perfusion, which might provide a new therapeutic approach for sepsis."

Preclinical • Infectious Disease • Septic Shock

A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Grand Medical Pty Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

A trial in COVID19 patients suffering from severe lung infection to evaluate the safety and effect of infusion with STC3141 (clinicaltrialsregister.eu) - P2; N=25; Ongoing; Sponsor: Grand Medical Pty Ltd

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CXCL8 • IFNG • IL10 • IL12A • IL1B • IL2 • IL6 • TNFA

A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Grand Medical Pty Ltd.

New P1 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019（COVID-19）Pneumonia (clinicaltrials.gov) - P2a; N=25; Recruiting; Sponsor: Grand Medical Pty Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • CRP • PCR

A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019（COVID-19）Pneumonia (clinicaltrials.gov) - P2a; N=25; Not yet recruiting; Sponsor: Grand Medical Pty Ltd.

Clinical • New P2a trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • CRP • PCR