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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in sequential organ failure (SOFA) scores from baseline on day 7 value
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study used 0.9% sodium chloride injection without any active drug as a placebo control, which was comparable to the characteristics and appearance of the experimental drug Imitation. The investigational drug and placebo are packaged and coded by a third party independent of the investigator and cannot be directly distinguished. by IWRS assigns study medication to subjects. Before database locking, subjects, researchers, in addition to DSMB and independent statistical teams and sponsors (including subjects and families, study physicians, study nurses, clinical coordinators, monitors, data managers, and statisticians) all were blind to the allocation of investigational drugs.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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:
- •There is a confirmed or suspected infection;
- •The presence of infection-induced organ dysfunction, i.e., the Sequential Organ failure score (SOFA) ≥2, as known in If there is organ function impairment before infection, that is, SOFA score is greater than 0, it is necessary to compare SOFA score after infection Previous rise ≥2 points. (5) SOFA score ≤ 13 points; (6) The time from meeting the sepsis 3.0 diagnostic criteria to randomization does not exceed 48 hours; (7) Male and female subjects of reproductive age agreed to use an effective contraceptive method from the start of the study until 1 month after the end of dosing.
排除标准
- •(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:
- •Heart: New York Heart Association Heart Function Grade IV;
- •Lung: chronic respiratory failure requires long-term oxygen therapy;
- •Kidney: chronic kidney disease stage 4 or 5;
- •Liver: previous liver failure, hepatic encephalopathy or hepatic coma, gastrointestinal bleeding caused by portal hypertension in the past six months; Or Child-Pugh score ≥ 10 points. (3) Cancer patients with cachexia, or due to obstruction, space occupation, extrusion and other reasons, resulting in serious damage to organ function or internal bleeding, Those who have difficulty or have not yet undergone surgical treatment, or who have received chemotherapy or immunotherapy within the last month; (4) The subjects had severe immune deficiency or were using strong immunosuppression: granulocytosis (N<0.5×10^9/L), activity Blood tumor or stage III HIV infection; Are being treated with immune-inducing drugs such as anti-thymocyte globulin (ATG), Antilymphocyte globulin (ALG), interleukin-2 receptor a chain antibody (IL-2RA), and interleukin-6 receptor αantibody (IL-6RA), etc. Continuous use of glucocorticoid therapy for nearly 2 weeks with a daily dose exceeding 200mg equivalent to hydrocortisone; (5) There is active bleeding that is difficult to control effectively; (6) Currently requiring systemic administration of therapeutic doses of anticoagulants (except prophylactic doses); (7) aPTT > 1.5 times the upper limit of normal value; (8) Platelet count < 50 ×10^9/L; (9) The patient needs or is receiving extracorporeal membrane oxygenation (ECMO) treatment; (10) endangered status, the expected survival time is not more than 24 hours; (11) Cardiac arrest, acute myocardial infarction, or massive cerebral infarction in the past 1 week; (12) are receiving or require dialysis or kidney replacement treatment within 6 hours; (13) Combined with severe or more severe burns: the total surface area of the burn exceeds 30% or the area of the third-degree burn exceeds 10%; Or surface Less than 30% of the volume, but the body condition is heavier or have shock, compound injury, respiratory tract burning; (14) Allergic to the active ingredient of the test drug (methylcellobiose sulfate) or excipients (disodium hydrogen phosphate and sodium dihydrogen phosphate); (15) Participants had participated in another clinical study (except those who did not receive intervention) or were participating in another trial within 1 month prior to screening Clinical treatment; (16) The subject's previous or ongoing disease, physical examination or laboratory test results are abnormal, as determined by the investigator to be probable Adversely affect the subject's safety in the study, or may affect the assessment of the subject's clinical or mental state By a wide margin.
研究组 & 干预措施
High dose group
The experimental drug was administered intravenously for 5 days
干预措施: STC314 Injection/STC314 Injection Placebo (Drug)
low dose group
The experimental drug was administered intravenously for 5 days
干预措施: STC314 Injection/STC314 Injection Placebo (Drug)
Placebo
Placebo infusion continued for 5 days
干预措施: STC314 Injection/STC314 Injection Placebo (Drug)
结局指标
主要结局
Changes in sequential organ failure (SOFA) scores from baseline on day 7 value
时间窗: 7 days after the first dose
Changes in sequential organ failure (SOFA) scores from baseline on day 7 value
次要结局
未报告次要终点