Acute Ischemic StrokePhase 1NCT05200728
The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers
A Phase 1 study testing SIM1910-09 in people with Acute Ischemic Stroke and Cerebral Edema, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke, Cerebral Edema
- What is being tested?
- SIM1910-09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to 23 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese male or female healthy volunteers;
- The subject fully understood the purpose, procedure, requirements, study period and potential risks of the study, and have signed the informed consent form (ICF);
- Age 18-50 years (including the boundary value) at the date of signing ICF ;
- The weight of Male subjects is no less than 50 kg, the one of female subjects no less than 45 kg, and body mass index (BMI) should be in the range of 19-28 kg/m2 (including the boundary value)
Who cannot join
- Those who participated in blood donation with blood donation volume ≥400 mL within 3 months prior to the first drug administration, or those who received blood transfusion;
- Those who have a history of clinically significant drug allergy or allergic reaction, as determined by the investigator, and is known to be allergic to the study drug or any of the ingredients in the study drug;
- Those who have a history of drug addiction and/or alcohol abuse, or positive result in drugs and alcohol screening test, or have had a history of drug abuse in the past five years or have used drugs in the three months before screening; or positive result in urine drug screening test during screening period;
- Alcohol and tobacco users (drinking more than 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine; Smokers who smoke 5 or above cigarettes a day) and cannot abstain from smoking or alcohol during the trial period; Or positive result in urine cotinine test ;
- Fridericia method corrected QT interval (QTcF) > 450 msec in males or > 470 msec in female in 12-lead electrocardiogram;
- Those who have a definite disease history of important organs, such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic system and skeletal musculoskeletal system, which are not suitable for attending this study according to the investigator' judgement;
Show all 16Show fewer
- Those who have undergone any surgery operation within 6 months prior to the first dose;
- Those who have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before the first dose;
- Have taken any investigational drug within 3 months prior to the first dose;
- Have taken any prescription medicine or over-the-counter drug, any vitamin product, health care product or herbal medicine within 2 weeks prior to initial administration;
- Abnormalities in comprehensive physical examination (vital signs, physical examination, neurological examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead ECG, chest X-ray, cognitive function and other examinations, which are judged as clinically significant by investigators;
- Female subjects who are pregnant or in lactation, or who are unable to abstain from sex or unable to use effective non-pharmacological contraception during the study period and during 3 months after final dose, or who have had unprotected sexual intercourse in the 2 weeks prior to the first dose;
- The positive result in the Infectious disease screening (including HBSAG, HCV-AB, HIV-AB, syphilis antibody) ;
- Intake of grapefruit or grapefruits-containing products, foods or beverages containing caffeine, xanthine or alcohol within 48 hours prior to administration of the study drug; Or other factors of affecting drug absorption, distribution, metabolism, excretion.;
- Patients with a history of needle sickness or blood sickness, or resistance for blood collection or intolerance to venipuncture blood collection;
- Subjects with other inappropriate factors for attending this study judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, and PK Characteristics of SIM1910-09 After Single/Multiple Dosing in Healthy Chinese Volunteers
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke, Cerebral Edema
- Being tested
- SIM1910-09, Placebo
- Keywords
- brain edema, Acute ischemic stroke
- Medical subject headings
- Ischemic Stroke, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM1910-09Drug
Also called AER-271
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SIM1910-09 | Experimental | 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. Receives: Drug: SIM1910-09 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days after final dose
Secondary outcomes (5)
PK parameters: Peak Plasma Concentration (Cmax)
Maximum concentration of SIM1910-09 and SCR-6401 derived from plasma concentration-time profile (ng/mL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Within 1-2 weeks of final blood sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start6 Dec 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200728
- Sponsor's protocol ID
- SIM1910-09-AQP4-101
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, and PK Characteristics of SIM1910-09 After Single/Multiple Dosing in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT05200728
- Acronym / sponsor ID
- SIM1910-09-AQP4-101
- Conditions
- Acute Ischemic Stroke, Cerebral Edema
- Keywords
- brain edema, Acute ischemic stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM1910-09 | Experimental | Drug: SIM1910-09This 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. |
| Placebo | Placebo comparator | Drug: PlaceboThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese male or female healthy volunteers;
- The subject fully understood the purpose, procedure, requirements, study period and potential risks of the study, and have signed the informed consent form (ICF);
- Age 18-50 years (including the boundary value) at the date of signing ICF ;
- The weight of Male subjects is no less than 50 kg, the one of female subjects no less than 45 kg, and body mass index (BMI) should be in the range of 19-28 kg/m2 (including the boundary value)
Key exclusion criteria (16 listed)
- Those who participated in blood donation with blood donation volume ≥400 mL within 3 months prior to the first drug administration, or those who received blood transfusion;
- Those who have a history of clinically significant drug allergy or allergic reaction, as determined by the investigator, and is known to be allergic to the study drug or any of the ingredients in the study drug;
- Those who have a history of drug addiction and/or alcohol abuse, or positive result in drugs and alcohol screening test, or have had a history of drug abuse in the past five years or have used drugs in the three months before screening; or positive result in urine drug screening test during screening period;
- Alcohol and tobacco users (drinking more than 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine; Smokers who smoke 5 or above cigarettes a day) and cannot abstain from smoking or alcohol during the trial period; Or positive result in urine cotinine test ;
- Fridericia method corrected QT interval (QTcF) > 450 msec in males or > 470 msec in female in 12-lead electrocardiogram;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM1910-09Also: AER-271Part 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. | Drug | SIM1910-09 |
| PlaceboPart 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. | Drug | Placebo |
Primary outcome
the adverse events after single/multiple ascending dosing in healthy Chinese adult subjects
Time frame: 7 days after final dose
the number and the percentage of subjects with adverse event according to CTCAE V5.0
the clinically significant change from baseline of physical examinations after single/multiple ascending dosing in healthy Chinese adult subjects
Time frame: 7 days after final dose
the abnormal incidence of physicial assessment , including of the head, the neck, the chest, the abdomen, Musculoskeletal system, Superficial lymph node, the nervous system
the clinically significant change from baseline of the vital signs after single/multiple ascending dosing in healthy Chinese adult subjects
Time frame: 7 days after final dose
the abnormal incidence of the the body tempreture, the pulse rate, respiratory rate, the blood pressure
the clinically significant change from baseline of laboratory tests after single/multiple ascending dosing in healthy Chinese adult subjects
Time frame: 7 days after final dose
incidence of laboratory abnormalities, based on hematology, coagulation function, clinical chemistry, and urinalysis test results
the clinically significant change from baseline of 12-lead electrocardiograms after single/multiple ascending dosing in healthy Chinese adult subjects
Time frame: 7 days after final dose
the abnormal incidence of heart rate, PR, QT, QRS, QTcF based on the ECG recording
5 secondary outcomes
PK parameters: Peak Plasma Concentration (Cmax)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Area under the plasma concentration versus time curve (AUC)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Clearance (CL)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Half-life (t1/2)
Time frame: Within 1-2 weeks of final blood sample collection
PK parameters: Volume of distribution (V)
Time frame: Within 1-2 weeks of final blood sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM1910-09 in people with Acute Ischemic Stroke and Cerebral Edema, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the adverse events after single/multiple ascending dosing in healthy Chinese adult subjects (time frame: 7 days after final dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.