Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

1. health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. 2. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. 3. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. 4. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. 5. those who have a history of drug abuse within 6 months prior to screening. 6. use of illicit drugs within 3 months prior to screening. 7. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. 8. subject (female) who is pregnant or lactating at screening or during the trial. 9. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. 10. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. 11. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. 12. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. 13. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. 14. those who have special dietary requirements and cannot accept a standard diet. 15. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. 16. those who have previously used immunosuppressants or monoclonal antibodies for any reason. 17. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. 18. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. 19. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. 20. female subjects with a positive urine or blood pregnancy test at screening. 21. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics \[methamphetamine\], ketamine, ecstasy \[methylenedioxyamphetamine\], cannabis \[tetrahydrocannabinolate\]). 22. those who have acute illness from screening to day -1 admission. 23. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. 24. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

1. health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. 2. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. 3. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. 4. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. 5. those who have a history of drug abuse within 6 months prior to screening. 6. use of illicit drugs within 3 months prior to screening. 7. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. 8. subject (female) who is pregnant or lactating at screening or during the trial. 9. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. 10. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. 11. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. 12. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. 13. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. 14. those who have special dietary requirements and cannot accept a standard diet. 15. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. 16. those who have previously used immunosuppressants or monoclonal antibodies for any reason. 17. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. 18. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. 19. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. 20. female subjects with a positive urine or blood pregnancy test at screening. 21. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics \[methamphetamine\], ketamine, ecstasy \[methylenedioxyamphetamine\], cannabis \[tetrahydrocannabinolate\]). 22. those who have acute illness from screening to day -1 admission. 23. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. 24. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Nov. 16, 2021, 6:30 p.m. usa

health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. those who have a history of drug abuse within 6 months prior to screening. use of illicit drugs within 3 months prior to screening. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. subject (female) who is pregnant or lactating at screening or during the trial. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. those who have special dietary requirements and cannot accept a standard diet. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. those who have previously used immunosuppressants or monoclonal antibodies for any reason. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. female subjects with a positive urine or blood pregnancy test at screening. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]). those who have acute illness from screening to day -1 admission. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. those who have a history of drug abuse within 6 months prior to screening. use of illicit drugs within 3 months prior to screening. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. subject (female) who is pregnant or lactating at screening or during the trial. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. those who have special dietary requirements and cannot accept a standard diet. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. those who have previously used immunosuppressants or monoclonal antibodies for any reason. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. female subjects with a positive urine or blood pregnancy test at screening. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]). those who have acute illness from screening to day -1 admission. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Oct. 26, 2020, 11:31 p.m. usa

1. health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. 2. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. 3. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. 4. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. 5. those who have a history of drug abuse within 6 months prior to screening. 6. use of illicit drugs within 3 months prior to screening. 7. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. 8. subject (female) who is pregnant or lactating at screening or during the trial. 9. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. 10. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. 11. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. 12. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. 13. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. 14. those who have special dietary requirements and cannot accept a standard diet. 15. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. 16. those who have previously used immunosuppressants or monoclonal antibodies for any reason. 17. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. 18. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. 19. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. 20. female subjects with a positive urine or blood pregnancy test at screening. 21. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]). 22. those who have acute illness from screening to day -1 admission. 23. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. 24. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

1. health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities. 2. subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment. 3. those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion. 4. those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness. 5. those who have a history of drug abuse within 6 months prior to screening. 6. use of illicit drugs within 3 months prior to screening. 7. those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 ml), or blood transfusions or use of blood products. 8. subject (female) who is pregnant or lactating at screening or during the trial. 9. subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months. 10. use of any prescription, over-the-counter, or chinese herbal medicines within 2 weeks prior to screening. 11. those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study. 12. those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial. 13. those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 ml of beer or 45 ml of spirits containing 40% alcohol or 150 ml of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial. 14. those who have special dietary requirements and cannot accept a standard diet. 15. those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening. 16. those who have previously used immunosuppressants or monoclonal antibodies for any reason. 17. those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmhg, diastolic blood pressure 60-89 mmhg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °c, respiration 16-20 breaths/min. the specific situation will be comprehensively determined by the investigator. 18. those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant. 19. those who have one or more clinically significant tests of hepatitis b virological markers, hepatitis c virus antibodies, anti-human immunodeficiency virus antibodies, or anti-treponema pallidum-specific antibodies. 20. female subjects with a positive urine or blood pregnancy test at screening. 21. alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]). 22. those who have acute illness from screening to day -1 admission. 23. those who have taken any prescription, over-the-counter, chinese herbal medicines from screening to day -1 admission. 24. subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.