A Phase 1 interventional study of SIM1910-09 and Placebo in Acute Ischemic Stroke and Cerebral Edema, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the tolerability, safety, and pharmacokinetic characteristics of SIM1910-09 for injection after single/multiple dosing in healthy Chinese adult volunteers.
This is a double-blind, randomized, placebo-controlled, sequential-group study with intravenously (IV) administered SIM1910-09 in healthy human subjects to assess the safety, tolerability and pharmacokinetic parameters, which include of single ascending dose part and multiple ascending doses part. The primary objectives of this study are to assess the safety and tolerability of SIM1910-09 in healthy subjects. Secondary objectives are to determine the pharmacokinetics of SIM1910-09 and SCR-6401 (primary metabolite) after administration of SIM1910-09. Exploratory objectives are to learn the inhibitory effect of SIM1910-09 and SCR-6401 on inflammation cytokine in ex vivo blood.
Exclusion Criteria:
This trial includes of 2 parts, Part A-single ascending doses and Part B- multiple ascending doses. Part A, there are 4 dose cohorts and each cohort will enroll 6 subjects to receive SIM1910-09. Part B, there are 4 dose cohorts and each cohort will enroll 6 subjects to receive SIM1910-09. The dose ascending will be determined by independent third party clinical physician. The next higher dose cohort could be initiated only if the stopping rules is not met.
Drug: SIM1910-09
This trial Includes of 2 parts, Part A-single ascending dose and Part B- multiple ascending dose. Part A, there are 4 dose cohorts and each cohort will enroll 2 subjects to receive placebo. Part B, there are 4 dose cohorts and each cohort will enroll 2 subjects to receive placebo. The dose ascending will be determined by independent third party clinical physician. The next higher dose cohort could be initiated only if the stopping rules is not met.
Drug: Placebo
Part A-single ascending doses， SIM1910-09 will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose. Part B-multiple ascending doses, SIM1910-09 will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion，which will be tested sequentially from low dose to high dose.
Also known as: AER-271
Part A-single ascending doses， placebo will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose. Part B-multiple ascending doses, placebo will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion，which will be tested sequentially from low dose to high dose.
the adverse events after single/multiple ascending dosing in healthy Chinese adult subjects
the number and the percentage of subjects with adverse event according to CTCAE V5.0
Time frame: 7 days after final dose
the clinically significant change from baseline of physical examinations after single/multiple ascending dosing in healthy Chinese adult subjects
the abnormal incidence of physicial assessment , including of the head, the neck, the chest, the abdomen, Musculoskeletal system, Superficial lymph node, the nervous system
Time frame: 7 days after final dose
the clinically significant change from baseline of the vital signs after single/multiple ascending dosing in healthy Chinese adult subjects
the abnormal incidence of the the body tempreture, the pulse rate, respiratory rate, the blood pressure
Time frame: 7 days after final dose
the clinically significant change from baseline of laboratory tests after single/multiple ascending dosing in healthy Chinese adult subjects
incidence of laboratory abnormalities, based on hematology, coagulation function, clinical chemistry, and urinalysis test results
Time frame: 7 days after final dose
the clinically significant change from baseline of 12-lead electrocardiograms after single/multiple ascending dosing in healthy Chinese adult subjects
the abnormal incidence of heart rate, PR, QT, QRS, QTcF based on the ECG recording
Time frame: 7 days after final dose
PK parameters: Peak Plasma Concentration (Cmax)
Maximum concentration of SIM1910-09 and SCR-6401 derived from plasma concentration-time profile (ng/mL)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Area under the plasma concentration versus time curve (AUC)
Maximum concentration of SIM1910-09 and SCR-6401 derived from plasma concentration-time profile (h\*ng/mL)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Clearance (CL)
Clearance of SIM1910-09 derived from plasma concentration-time profile (mL/h/kg)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Half-life (t1/2)
Half-life of SIM1910-09 and SCR-6401 derived from plasma concentration-time profile (h)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Volume of distribution (V)
Volume of distribution of SIM1910-09 derived from plasma concentration-time profile (mL/kg)
Time frame: Within 1-2 weeks of final blood sample collection
Exploratory outcome: The cytokines Concentrations of interleukin 1β (IL-1β)
The cytokines Concentrations of IL-1β in ex-vivo blood after in-vitro stimulation and the blood sampling was token before and after single/multiple ascending dose
Time frame: Within one week of final blood sample collection
Exploratory outcome: The cytokines Concentrations of interleukin 6 (IL-6)
The cytokines Concentrations of IL-6 in ex-vivo blood after in-vitro stimulation and the blood sampling was token before and after single/multiple ascending dose
Time frame: Within one week of final blood sample collection
Exploratory outcome: The cytokines Concentrations of tumor necrosis factor α (TNF-α)
The cytokines Concentrations of TNF-α in ex-vivo blood after in-vitro stimulation and the blood sampling was token before and after single/multiple ascending dose
Time frame: Within one week of final blood sample collection
Exploratory outcome: The cytokines Concentrations of interferon γ (IFN-γ)
The cytokines Concentrations of IFN-γ in ex-vivo blood after in-vitro stimulation and the blood sampling was token before and after single/multiple ascending dose
Time frame: Within one week of final blood sample collection
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Jiangsu Simcere Pharmaceutical Co., Ltd.