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| Name | Class |
|---|---|
| Grand Pharmaceutical (China) Co., Ltd. | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STC314 injection or Placebo(rate=58.3 mg/hr) | Drug | To receive continuous infusion of STC314/Placebo injection at rate 58.3mg/hr up to 3 days (72hours). Also to receive appropriate standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of STC314 injection in patients with ARDS. | The incidence of adverse event (AE) and serious adverse event (SAE); | Within 28 days after the start of treatment |
| To evaluate the safety of STC314 injection in patients with ARDS. | Rates of Treatment Discontinuation Due to Adverse Events; | Within 28 days after the start of treatment |
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | maximum concentration (Cmax) | Through 0 to144 hours after the start of treatment |
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | area under the plasma concentration-time curve (AUC0-t, AUC0-inf) | Through 0 to144 hours after the start of treatment |
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | time to peak (Tmax) | Through 0 to144 hours after the start of treatment |
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | elimination half Decay (t1/2) | Through 0 to144 hours after the start of treatment |
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | elimination rate constant(Kel) | Through 0 to144 hours after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Changes of the value of blood lactate from baseline after dosing | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. |
| Measure | Description | Time Frame |
|---|---|---|
| As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated. | Change of the level of Histone in plasma after dosing | Through 0 to144 hours after the start of treatment |
| As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated. |
Inclusion Criteria:
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)ï¼›
The following 2012 Berlin definition criteria for mild to moderate ARDS were met:
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.
Exclusion Criteria:
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:
History of one of the following within 4 weeks prior to screening:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Pang, PhD | Contact | +61 466555916 | jpang@grandpharma.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| STC314 injection or Placebo(rate=87.5 mg/hr) | Drug | To receive continuous infusion of STC314/Placebo injection at rate 87.5mg/hr up to 3 days (72hours). Also to receive appropriate standard of care. |
|
| To evaluate the pharmacokinetic of STC314 injection in patients with ARDS. | clearance (CL) | Through 0 to144 hours after the start of treatment |
Change of Oxygenation Index (PaO2/FiO2) from baseline after dosing
| Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Change of Murray Lung Injury Score from baseline.(range 0-4, higher score means more severe lung injury) | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Change of the value of serum creatinine from baseline after dosing | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Change of the value of bilirubin from baseline after dosing | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Change of the value of Alanine Transaminase(ALT) from baseline after dosing | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Change of Sequential Organ Failure Assessment score from baseline after dosing.(range 0-4, higher score means a worse prognosis) | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | all-cause mortality within 28 days | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Ventilator-free survival time within 28 days | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | Hospitalization time within 28 days | Within 28 days after the start of treatment |
| To evaluate the efficacy of STC314 injection in patients with ARDS. | length of ICU stay within 28 days | Within 28 days after the start of treatment |
Change of the level of Neutrophil extracellular traps(NETs)-related variables in plasma after dosing [myelinated Oxidase (MPO), citrullinated histone H3 (CitH3), circular free DNA (cfDNA)] |
| Through 0 to144 hours after the start of treatment |
| As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated. | Change of the level of inflammatory factor interleukin-6 (IL-6) after dosing | Through 0 to144 hours after the start of treatment |
| Wuhan Jinyintan Hospital | Not yet recruiting | Wuhan | Hubei | China |
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| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C000717107 | STC3141 |
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