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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
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.
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.
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGWuhan Jinyintan Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGWuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGTo evaluate the safety of STC314 injection in patients with ARDS.
The incidence of adverse event (AE) and serious adverse event (SAE);
Time frame: 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;
Time frame: Within 28 days after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
maximum concentration (Cmax)
Time frame: 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)
Time frame: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
time to peak (Tmax)
Time frame: 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)
Time frame: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
elimination rate constant(Kel)
Time frame: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Xiangya Hospital Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGZhongda Hospital Southeast University
Nanjing, Jiangsu, China
RECRUITINGclearance (CL)
Time frame: Through 0 to144 hours after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Changes of the value of blood lactate from baseline after dosing
Time frame: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of Oxygenation Index (PaO2/FiO2) from baseline after dosing
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Hospitalization time within 28 days
Time frame: 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
Time frame: Within 28 days after the start of treatment