A Phase 2 interventional study of STC314 Injection/STC314 Injection Placebo in Sepsis, sponsored by Grand Medical Pty Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Grand Medical Pty Ltd. · Phase 2, Interventional, and Treatment
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
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 180 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Grand Medical Pty Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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(1) 18≤ age ≤80 years old, gender is not limited; (2) The subjects or their guardians voluntarily participate in the study and sign the informed consent; (3) being treated in an intensive care unit; (4) Meet the diagnostic criteria for sepsis 3.0, namely:
Exclusion Criteria:
(1) The pregnancy test of women of childbearing age before administration is positive, and pregnant or lactating women; (2) Chronic disease has caused serious organ function impairment, or has caused serious complications:
The experimental drug was administered intravenously for 5 days
Drug: STC314 Injection/STC314 Injection Placebo
The experimental drug was administered intravenously for 5 days
Drug: STC314 Injection/STC314 Injection Placebo
Placebo infusion continued for 5 days
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.
Also known as: STC314 Injection Placebo
Changes in sequential organ failure (SOFA) scores from baseline on day 7 value
Changes in sequential organ failure (SOFA) scores from baseline on day 7 value
Time frame: 7 days after the first dose
Started Nov 2023 (actual). Primary completion is estimated for Nov 2024, 12 months after the start.
Of 46 phase 2 interventional studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 35. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Grand Medical Pty Ltd.