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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111523
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Suzhou Yabao Pharmaceutical R&D Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Cerebral Apoplexy Drug: SY-007 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Parallel, Placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-007 After Single-dose Incremental Intravenous Injection in Healthy Subjects
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Placebo Comparator: SY-007 dose 1
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo

Placebo Comparator: SY-007 dose 2
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo

Placebo Comparator: SY-007 dose 3
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo

Placebo Comparator: SY-007 dose 4
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo

Placebo Comparator: SY-007 dose 5
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo

Placebo Comparator: SY-007 dose 6
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.
Drug: SY-007
A single dose of SY-007 or placebo injection(1mg-45mg)
Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Area under curve (AUC) of SY-007 following injection of single dose [ Time Frame: 6 hours ]
    To mearsure the study drug concentration in blood samples which collected after injection

  2. Cmax of SY-007 following injection of single dose [ Time Frame: 6 hours ]
    To mearsure the study drug concentration in blood samples which collected after injection

  3. Tmax of SY-007 following injection of single dose [ Time Frame: 6 hours ]
    To mearsure the study drug concentration in blood samples which collected after injection

  4. T1/2 of SY-007 following injection of single dose [ Time Frame: 6 hours ]
    To mearsure the study drug concentration in blood samples which collected after injection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111523


Contacts
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Contact: Zheng Li, Doctor 028-85423655 18980601950@163.com
Contact: Wang Zhenlei, Doctor 028-85423655 zhenleiwang@qq.com

Locations
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China, Sichuan
West China Hospital of Sichuan University Recruiting
Chendu, Sichuan, China, 610041
Contact: Zheng Li, Doctor    028-85423655    18980601950@163.com   
Contact: Wang Zhenlei, Doctor    028-85423655    zhenleiwang@qq.com   
Principal Investigator: Zheng Li, Doctor         
Principal Investigator: Wang Zhenlei, Doctor         
Sponsors and Collaborators
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Investigators
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Principal Investigator: Zheng Li, Doctor West China Hospital
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Responsible Party: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
ClinicalTrials.gov Identifier: NCT04111523    
Other Study ID Numbers: SY007001
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases