NCT05000671Unknown1 期
A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Continuous Intravenous Infusion of STC314 Injection in Chinese Patients With Acute Respiratory Distress Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- To evaluate the safety of STC314 injection in patients with ARDS.
研究概览
简要总结
This study is a Randomized, Double-blinded, Placebo-controlled Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STC314 Injection Administered as Continuous Intravenous Infusion in Chinese Patients with ARDS (Acute Respiratory Distress Syndrome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age ≤ 70 years, male or female;
- •Voluntarily participate in the study and sign the informed consent form;
- •Diagnosis of ARDS for no more than 48 hours (starting at the time of diagnosis recorded in the medical record)；
- •The following 2012 Berlin definition criteria for mild to moderate ARDS were met:
- •From known clinical impairment and new or worsening of respiratory symptoms to fulfillment of diagnostic criteria is less than 7 days(inclusive).
- •Chest imaging suggests bilateral infiltrates. The effusion, lobar/atelectasis, or nodules cannot completely explain the phenomenon.
- •Respiratory failure cannot be completely explained by heart failure or fluid overload;
- •When PEEP or CPAP ≥5 cm H2O, 100 mmHg≤PaO2/FiO2≤300 mmHg;
- •Male subjects agree to use an effective contraceptive method from the start of the study until 7 days after the end of treatment; Female subjects of childbearing age agree to use an effective contraceptive method from the start of the study until 3 months after the end of treatment.
排除标准
- •Positive serum pregnancy test before dosing for women of childbearing potential, pregnant women, or lactating women;
- •Terminal phase of chronic disease with an expected survival of no more than 6 months;
- •Combined with one of the following chronic organ damage or immunosuppressive diseases:
- •Heart: New York Heart Association functional class IV;
- •Lung: severe lung disease, including pulmonary hypertension, oxygen therapy or ventilator dependence for more than one month cumulatively within the first six months of screening, end-stage lung disease, or severe exercise limitation caused by chest wall malformations;
- •Kidney: ongoing long-term dialysis treatment;
- •Liver: biopsy confirmed cirrhosis and portal hypertension, or previous upper gastrointestinal bleeding caused by portal hypertension; Liver failure, hepatic encephalopathy, or hepatic coma;
- •Immunosuppression: with lymphoma, leukemia or acquired immunodeficiency; Received anti-tumor chemotherapy in the last 3 months, or ongoing immunosuppressive therapy due to organ transplantation, immune diseases, etc.; Has undergone allogeneic bone marrow transplantation or hematopoietic stem cell transplantation; Steroid hormone therapy in the last 3 months (equivalent to > 0.5 mg/kg/day prednisone continued 1 month);
- •History of one of the following within 4 weeks prior to screening:
- •Acute pulmonary embolism;
- •Cardiac arrest;
- •Acute myocardial infarction;
- •eGFR < 60 mL/min/BSA (calculated using CG formula);
- •ALT > 5 x ULN, or total bilirubin > 2 x ULN;
- •Severe anemia (hemoglobin < 7.0 g/dL);
- •Absolute neutrophil count < 1500/μL;
- •Platelet count < 50,000/μL;
- •aPTT > 1.5 × ULN;
- •Active bleeding that cannot be effectively controlled;
- •The subject required therapeutic doses of heparin or was taking anticoagulants;
- •ARDS caused by direct lung injury due to physical or chemical causes;
- •Severe or greater burns: the overall surface area of burns exceeds 30% or the III degree burn area exceeds 10%; or the total area is less than 30%, but the general condition is severe or has shock, combined injury, respiratory tract burn;
- •Allergic to the active ingredients or excipients of the study drug;
- •Subjects have participated in other clinical studies (other than those who have not received intervention) or are participating in other experimental treatments within 1 month prior to screening;
- •In the opinion of the investigator, the subject could not benefit from the study or was not suitable for participation in the study.
研究组 & 干预措施
Cohort 1
Experimental
Drug: STC314/Placebo injection Continuous infusion at rate 58.3mg/hr up to 3 days (72 hours) N=8(Randomization-STC314/Placebo injection=3:1)
干预措施: STC314 injection or Placebo(rate=58.3 mg/hr) (Drug)
Cohort 2
Experimental
Drug: STC314/Placebo injection Continuous infusion at rate 87.5mg/hr up to 3 days (72 hours) N=8(Randomization-STC314/Placebo injection=3:1)
干预措施: STC314 injection or Placebo(rate=87.5 mg/hr) (Drug)
结局指标
主要结局
To evaluate the safety of STC314 injection in patients with ARDS.
时间窗: Within 28 days after the start of treatment
Rates of Treatment Discontinuation Due to Adverse Events;
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
时间窗: Through 0 to144 hours after the start of treatment
clearance (CL)
次要结局
- To evaluate the efficacy of STC314 injection in patients with ARDS.(Within 28 days after the start of treatment)
研究者
研究点 (5)
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