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

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: 1. hiv antibody positive; 2. hbsag positive; 3. hcv antibody positive; 4. history of tuberculosis or lung disease as reported by subject; 5. as reported by 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 6. female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; 7. subjects who participated in any other clinical study within 30 days prior to screening; 8. subjects with known allergic reactions to the study drug or its excipients; 9. 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: 1. poor venous access or issues with needle sticks, e.g., syncope 2. donated or lost \>500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission 10. any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: 1. hiv antibody positive; 2. hbsag positive; 3. hcv antibody positive; 4. history of tuberculosis or lung disease as reported by subject; 5. as reported by 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 6. female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; 7. subjects who participated in any other clinical study within 30 days prior to screening; 8. subjects with known allergic reactions to the study drug or its excipients; 9. 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: 1. poor venous access or issues with needle sticks, e.g., syncope 2. donated or lost \>500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission 10. any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

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

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: hiv antibody positive; hbsag positive; hcv antibody positive; history of tuberculosis or lung disease as reported by subject; as reported by 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 30 days prior to screening; subjects with known allergic reactions to the study drug or its excipients; 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: poor venous access or issues with needle sticks, e.g., syncope donated or lost >500 ml of blood in the previous 3 months a history of prescription drug abuse, illicit drug use within 9 months prior to screening a positive screen for alcohol or drugs of abuse at screening or admission any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: hiv antibody positive; hbsag positive; hcv antibody positive; history of tuberculosis or lung disease as reported by subject; as reported by 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 30 days prior to screening; subjects with known allergic reactions to the study drug or its excipients; 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: poor venous access or issues with needle sticks, e.g., syncope donated or lost >500 ml of blood in the previous 3 months a history of prescription drug abuse, illicit drug use within 9 months prior to screening a positive screen for alcohol or drugs of abuse at screening or admission any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Oct. 7, 2021, noon usa

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: 1. hiv antibody positive; 2. hbsag positive; 3. hcv antibody positive; 4. history of tuberculosis or lung disease as reported by subject; 5. as reported by 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 6. female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; 7. subjects who participated in any other clinical study within 30 days prior to screening; 8. subjects with known allergic reactions to the study drug or its excipients; 9. 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: 1. poor venous access or issues with needle sticks, e.g., syncope 2. donated or lost >500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission 10. any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

subjects are required to meet none of the following criteria for enrollment into the part 1 of the study: 1. hiv antibody positive; 2. hbsag positive; 3. hcv antibody positive; 4. history of tuberculosis or lung disease as reported by subject; 5. as reported by 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 6. female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; 7. subjects who participated in any other clinical study within 30 days prior to screening; 8. subjects with known allergic reactions to the study drug or its excipients; 9. 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: 1. poor venous access or issues with needle sticks, e.g., syncope 2. donated or lost >500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission 10. any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Feb. 25, 2021, 7:58 p.m. usa

- 1) hiv antibody positive; - 2) hbsag positive; - 3) hcv antibody positive; - 4) history of tuberculosis or lung disease; - 5) 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; - 6) female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; - 7) subjects who participated in any other clinical study within 30 days prior to screening; - 8) subjects with known allergic reactions to the study drug or its excipients; - 9) 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; 1. poor venous access or issues with needle sticks e.g., syncope 2. donated or lost >500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission - 10) any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

- 1) hiv antibody positive; - 2) hbsag positive; - 3) hcv antibody positive; - 4) history of tuberculosis or lung disease; - 5) 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; - 6) female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; - 7) subjects who participated in any other clinical study within 30 days prior to screening; - 8) subjects with known allergic reactions to the study drug or its excipients; - 9) 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; 1. poor venous access or issues with needle sticks e.g., syncope 2. donated or lost >500 ml of blood in the previous 3 months 3. a history of prescription drug abuse, illicit drug use within 9 months prior to screening 4. a positive screen for alcohol or drugs of abuse at screening or admission - 10) any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.