Created at Source Raw Value Validated value
June 25, 2024, noon usa

subject meeting any of the following criteria will be excluded from the study: 1. subject has a medical history or current presence of disease including one or more of the following(s): 1. history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator 3. history of or any concomitant active malignancy 4. history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c 5. history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration 6. history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization 7. history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. any vaccination within 4 weeks prior to the study drug administration 3. treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

subject meeting any of the following criteria will be excluded from the study: 1. subject has a medical history or current presence of disease including one or more of the following(s): 1. history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator 3. history of or any concomitant active malignancy 4. history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c 5. history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration 6. history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization 7. history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. any vaccination within 4 weeks prior to the study drug administration 3. treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

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

subject meeting any of the following criteria will be excluded from the study: subject has a medical history or current presence of disease including one or more of the following(s): history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator history of or any concomitant active malignancy history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period subject had a history of or concurrent use of medications including any prior therapy of following(s): prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration any vaccination within 4 weeks prior to the study drug administration treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

subject meeting any of the following criteria will be excluded from the study: subject has a medical history or current presence of disease including one or more of the following(s): history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator history of or any concomitant active malignancy history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period subject had a history of or concurrent use of medications including any prior therapy of following(s): prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration any vaccination within 4 weeks prior to the study drug administration treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

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

subject meeting any of the following criteria will be excluded from the study: 1. subject has a medical history or current presence of disease including one or more of the following(s): 1. history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator 3. history of or any concomitant active malignancy 4. history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c 5. history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration 6. history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization 7. history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. any vaccination within 4 weeks prior to the study drug administration 3. treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

subject meeting any of the following criteria will be excluded from the study: 1. subject has a medical history or current presence of disease including one or more of the following(s): 1. history of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. history of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the investigator 3. history of or any concomitant active malignancy 4. history of or current infection with human immunodeficiency, syphilis, hepatitis b or hepatitis c 5. history of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required iv antibiotics) within 6 months before the study drug administration 6. history of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator or requires hospitalization 7. history of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. any vaccination within 4 weeks prior to the study drug administration 3. treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration