Created at Source Raw Value Validated value
Oct. 17, 2022, 10:36 a.m. usa

hiv antibody positive; hbsag positive; hcv antibody positive; syphilis spirochetes antibody positive; history of tuberculosis or lung disease as reported by subject; subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretations; female subjects who are pregnant, lactating or have pregnancy plans and cannot contracept as required; subjects who participated in any other clinical study within 3 months prior to screening; subjects with known allergic reactions to the study drug or its excipients; subjects donated or lost ≥ 400 ml 3 months prior to the administration of study drugs; or subjects donated (including aphersis donation) or lost ≥ 200 ml 1 month prior to the administration; subjects who have taken any drug that inhibits or induces hepatic drug-metabolizing enzymes (e.g., inducers: barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors: antidepressants like selective serotonin reuptake inhibitor (ssri), cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration; or subjects who have taken any prescription, over-the-counter, and herbal medications other than those listed above within 14 days prior to administration; alcoholics or regular drinkers within 3 months, i.e., those who comsume more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of liquor with 40% abv or 150 ml of wine), or those who have a positive result in breath alcohol test; use of any medication, including prescription, over-the-counter, vitatmins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first administration, in the investigator's judgment, which may influence study results or subjects' safety; any other clinical condition that, in the inverstigator's judgement, would potentially compromise study compliance or the abilityti evaluate safety and efficacy.

hiv antibody positive; hbsag positive; hcv antibody positive; syphilis spirochetes antibody positive; history of tuberculosis or lung disease as reported by subject; subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretations; female subjects who are pregnant, lactating or have pregnancy plans and cannot contracept as required; subjects who participated in any other clinical study within 3 months prior to screening; subjects with known allergic reactions to the study drug or its excipients; subjects donated or lost ≥ 400 ml 3 months prior to the administration of study drugs; or subjects donated (including aphersis donation) or lost ≥ 200 ml 1 month prior to the administration; subjects who have taken any drug that inhibits or induces hepatic drug-metabolizing enzymes (e.g., inducers: barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors: antidepressants like selective serotonin reuptake inhibitor (ssri), cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration; or subjects who have taken any prescription, over-the-counter, and herbal medications other than those listed above within 14 days prior to administration; alcoholics or regular drinkers within 3 months, i.e., those who comsume more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of liquor with 40% abv or 150 ml of wine), or those who have a positive result in breath alcohol test; use of any medication, including prescription, over-the-counter, vitatmins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first administration, in the investigator's judgment, which may influence study results or subjects' safety; any other clinical condition that, in the inverstigator's judgement, would potentially compromise study compliance or the abilityti evaluate safety and efficacy.

Jan. 20, 2022, 11:30 a.m. usa

hiv antibody positive; hbsag positive; hcv antibody positive; treponema pallidum antibody is positive; history of tuberculosis or lung disease; the subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretation; female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; subjects who participated in any other clinical study within 3 months prior to screening; subjects with known allergic reactions to the study drug or its excipients; blood donation or blood loss ≥400ml within 3 months prior to drug administration, or blood transfusion; blood donation (including component blood donation) or blood loss ≥200ml within 1 month before drug administration; any drugs that inhibit or induce drug metabolism enzymes in the liver (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ssri antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or any prescription, over-the-counter, or herbal medicines other than those mentioned above within 14 days prior to the administration of the study drug; alcoholics or regular drinkers in the 3 months prior to the study,or a positive screen for alcohol or drugs of abuse at screening or admission use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

hiv antibody positive; hbsag positive; hcv antibody positive; treponema pallidum antibody is positive; history of tuberculosis or lung disease; the subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretation; female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; subjects who participated in any other clinical study within 3 months prior to screening; subjects with known allergic reactions to the study drug or its excipients; blood donation or blood loss ≥400ml within 3 months prior to drug administration, or blood transfusion; blood donation (including component blood donation) or blood loss ≥200ml within 1 month before drug administration; any drugs that inhibit or induce drug metabolism enzymes in the liver (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ssri antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or any prescription, over-the-counter, or herbal medicines other than those mentioned above within 14 days prior to the administration of the study drug; alcoholics or regular drinkers in the 3 months prior to the study,or a positive screen for alcohol or drugs of abuse at screening or admission use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.