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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
Full 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.
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Inclusion criteria
(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:
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Interventional model
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180 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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