Cerebral ApoplexyPhase 1NCT04111523

Single-dose Incremental Intravenous Injection of SY-007 in Healthy Subjects

A Phase 1 study testing SY-007 in people with Cerebral Apoplexy, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a single-dose incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Cerebral Apoplexy
What is being tested?: SY-007
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteChina
Study dates: 5 Mar 2019to 26 May 2020
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults aged 18-45 (including two values);
Both men and women have the same dose, and the number of single-sex subjects in the same dose group is not less than one third of the number in the dose group;
During the screening period, the body weight of male subjects is greater than or equal to 50kg, and that of female subjects is greater than or equal to 45kg, with a body mass index (BMI = weight/height squared (kg/m2)) in the range of 18 to 26 (including both ends);
Medical history, physical examination, other laboratory examination items and examination related to the test before the test. All the tests were normal or not clinically significant mild abnormalities, clinical research doctors judged that qualified.
No cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic abnormalities and other diseases medical history.
The venous channel is normal and blood samples can be fully collected according to the plan;
Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent;
Subjects are willing to take effective contraceptive measures, and have pregnancy plane during and within 3 months after the stud. Female subjects should be non-lactating, have negative pregnancy test, or have no fertility potential. Women who have been without a uterus for at least 12 months or are considered to have no potential pregnancy.

Who cannot join

He/she who has the disease of the nervous system, such as basal ganglia disease, alzheimer's disease, Parkinson's disease, Parkinson's disease, epilepsy history or family history, or who is at risk of the disease through the investigation of Magnetic Resonance Imaging (MRI)/Electroencephalogram (EEG);
Those who have a history of drug or other allergies, or may be allergic to the study drug or any component of the study drug in the judgment of the researcher;
Those who have participated in the clinical trial of any drug or medical device within 3 months prior to the screening, or who are still within 5 half-lives of the drug before the screening (the half-lives of the drug under test are longer, and the half-lives of the drug under test are more than 3 months), are judged not suitable for this study by the researchers;
Have a history of alcohol abuse and drug abuse;
Those who donated blood at least 400 mL within the first 4 weeks of screening, had severe blood loss and the blood loss was at least 400 mL, or had received blood transfusion within 8 weeks;
Women who consume more than 15 g of alcohol a day and men who consume more than 25 g of alcohol (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine or 50 mL of low-alcohol liquor) twice a week;Participants were reluctant to stop drinking between 24 hours before the study began and the end of the study;

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Those who smoke more than 5 cigarettes a day or are unwilling/unable to stop nicotine intake during the study period;
Abnormal chest X-ray examination with clinical significance;
12-lead ecg showed clinically significant abnormalities. After correction of QTc interphase >450 msec, the researcher believed that participating in the experiment would increase the risk of subjects;
Viral serological evidence during screening: patients with positive hepatitis b surface antigen (HBsAg), positive anti-hcv, or positive anti-HIV antibody of human immunodeficiency virus (HIV), or positive anti-tp antibody of treponema pallidum;
Patients who have undergone major surgery within 4 weeks before drug administration;
Those who have been screened for the first 4 weeks or plan to receive live (attenuated) vaccines during the trial;
Fertile eligible subjects (male and female) will not agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study period and at least 3 months after administration;
The blood pregnancy test of women of child-bearing age was positive.A woman who is pregnant or breast-feeding;
Those who have used other drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements, etc.) within one week prior to the screening;
History of malignant tumor diseases;
Patients with acute disease and medication 2 weeks before the test;
The sponsor or the investigator decides that the investigator is not suitable to participate in the study; Women who have been without a uterus for at least 12 months or are considered to have no potential pregnancy.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-007 After Single-dose Incremental Intravenous Injection in Healthy Subjects

This study is a single-dose incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

Read the detailed description

Six dose-group trials are planned: 1 mg,4 mg,10 mg,20 mg,30 mg,and 45 mg.When the dose reaches 45mg, if the standard of increasing dose termination is still not reached, the researcher and the sponsor shall decide whether to continue the increasing dose after reviewing the previous study data, and each increasing dose shall not exceed 33.3% (e.g., 60mg) of the previous dose group. In the process of dose increasing, when the dose exceeds 20 mg, if the dose level reaches the dose termination standard, an intermediate dose is set between this dose and the previous dose, and the study is returned to the intermediate dose group.In this study, a parallel design was adopted, in which each subject received only one dose of drug from one dose group, which ensured the safety of the subject to the greatest extent, and also avoided the interference of safety and PK results caused by possible insufficient elution or other factors.Among them, 1 mg dose group was the starting dose group, and 6 subjects were randomly assigned into sy-007 group for injection or placebo group at a ratio of 2:1. Only 2 subjects were given the drug for the first time. One day after the first two subjects were given the drug, after ensuring the safety of the first two subjects, the drug was given to the remaining 4 subjects.In other dose groups, sentry administration was also used. The first 2 subjects received sy-007 injection or placebo respectively. After 3 days of hospitalization observation, the safety data of the first 2 cases were reviewed by the researcher and the sponsor, and the remaining subjects in this dose group were determined accordingly.Pharmacokinetic biological samples were collected from all dose groups and their safety was assessed.A total of 66~90 healthy subjects will be enrolled.

Conditions: Cerebral Apoplexy
Being tested: SY-007
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SY-007Drug
A single dose of SY-007 or placebo injection(1mg-45mg)

Study groups in NCT04111523
Study group	Role	What they receive
SY-007 dose 1	Experimental	The study will be intiated in healthy subjects at a 1mg dose. Six subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 2:1. Receives: Drug: SY-007
SY-007 dose 2	Experimental	The study will be intiated in healthy subjects at a 4mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1. Receives: Drug: SY-007
SY-007 dose 3	Experimental	The study will be intiated in healthy subjects at a 10mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1. Receives: Drug: SY-007
SY-007 dose 4	Experimental	The study will be intiated in healthy subjects at a 20mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1. Receives: Drug: SY-007
SY-007 dose 5	Experimental	The study will be intiated in healthy subjects at a 30mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1. Receives: Drug: SY-007
SY-007 dose 6	Experimental	The study will be intiated in healthy subjects at a 45mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1. Receives: Drug: SY-007

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events of SY-007
Incidence of adverse events of SY-007, collecting number of subjects with adverse events as assessed by CTCAE V5.0. Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal laboratory values, abnormal vital signs, abnormal physical examination, abnormal ECG data.
Measured: 7 days

Secondary outcomes (4)

Area under curve (AUC) of SY-007 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: 6 hours
Cmax of SY-007 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: 6 hours
Tmax of SY-007 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: 6 hours
T1/2 of SY-007 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201926 May 2020

First posted1 Oct 2019
Study start5 Mar 2019
Primary completion26 May 2020
Study completion26 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral ApoplexyStudies of the same condition, open and under way.
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: Factorial
Model description: Parallel, Placebo control
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04111523
Sponsor's protocol ID: SY007001
Status last verified: Feb 2021
First submitted: 29 Sep 2019
Last updated: 6 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Apoplexy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-007 After Single-dose Incremental Intravenous Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT04111523
Acronym / sponsor ID: SY007001
Conditions: Cerebral Apoplexy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Mar 2019 (actual)
Primary completion: 26 May 2020 (actual)
Study completion: 26 May 2020 (actual)
First posted: 1 Oct 2019 (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 study is a single-dose incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: Parallel, Placebo control

Arm	Type	Receives
SY-007 dose 1	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 1mg dose. Six subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 2:1.
SY-007 dose 2	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 4mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1.
SY-007 dose 3	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 10mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1.
SY-007 dose 4	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 20mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1.
SY-007 dose 5	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 30mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1.
SY-007 dose 6	Experimental	Drug: SY-007The study will be intiated in healthy subjects at a 45mg dose. Twelve subjects will be envolved in this study, and the proportion of subjects injected SY-007 to placebo is 5:1.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy adults aged 18-45 (including two values);
Both men and women have the same dose, and the number of single-sex subjects in the same dose group is not less than one third of the number in the dose group;
During the screening period, the body weight of male subjects is greater than or equal to 50kg, and that of female subjects is greater than or equal to 45kg, with a body mass index (BMI = weight/height squared (kg/m2)) in the range of 18 to 26 (including both ends);
Medical history, physical examination, other laboratory examination items and examination related to the test before the test. All the tests were normal or not clinically significant mild abnormalities, clinical research doctors judged that qualified.
No cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic abnormalities and other diseases medical history.

Key exclusion criteria (18 listed)

He/she who has the disease of the nervous system, such as basal ganglia disease, alzheimer's disease, Parkinson's disease, Parkinson's disease, epilepsy history or family history, or who is at risk of the disease through the investigation of Magnetic Resonance Imaging (MRI)/Electroencephalogram (EEG);
Those who have a history of drug or other allergies, or may be allergic to the study drug or any component of the study drug in the judgment of the researcher;
Those who have participated in the clinical trial of any drug or medical device within 3 months prior to the screening, or who are still within 5 half-lives of the drug before the screening (the half-lives of the drug under test are longer, and the half-lives of the drug under test are more than 3 months), are judged not suitable for this study by the researchers;
Have a history of alcohol abuse and drug abuse;
Those who donated blood at least 400 mL within the first 4 weeks of screening, had severe blood loss and the blood loss was at least 400 mL, or had received blood transfusion within 8 weeks;

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
SY-007A single dose of SY-007 or placebo injection(1mg-45mg)	Drug	SY-007 dose 1, SY-007 dose 2, SY-007 dose 3, SY-007 dose 4, SY-007 dose 5, SY-007 dose 6

Primary outcome

Incidence of adverse events of SY-007
Time frame: 7 days
Incidence of adverse events of SY-007, collecting number of subjects with adverse events as assessed by CTCAE V5.0. Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal laboratory values, abnormal vital signs, abnormal physical examination, abnormal ECG data.

4 secondary outcomes

Area under curve (AUC) of SY-007 following injection of single dose
Time frame: 6 hours
Cmax of SY-007 following injection of single dose
Time frame: 6 hours
Tmax of SY-007 following injection of single dose
Time frame: 6 hours
T1/2 of SY-007 following injection of single dose
Time frame: 6 hours

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 6 May 2021.
Individual participant dataSharing planned: No

Related trials for Cerebral Apoplexy

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.

Zheng Li, Doctor principal investigator

West China 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 SY-007 in people with Cerebral Apoplexy, run by Suzhou Yabao Pharmaceutical R&D 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 8 inclusion and 18 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 6 May 2021. 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. 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?

Incidence of adverse events of SY-007 (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04111523.

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 6 May 2021.