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. (part of Simcere Pharmaceutical Group Limited) · 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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 68 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 78 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Dec 2021 to primary completion in Mar 2023, 15 months.
Of 42 phase 1 interventional studies under Ischemic Stroke, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 15 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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