Rheumatoid arthritis
Conditions
Interventions
7 groups:Proximod will be given by 7 dose levels: 0.125 mg, 0.25 mg, 0.5mg, 1.0mg, 1.5mg, 2.0mg, 3.0mg in seven groups, respectively
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 5) Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical value); 6) Health: has no heart,liver, kidney, gastrointestinal tract, nervous system, respiratory system, such as asthma, exercise induced asthma, chronic obstructive pulmonary disease history; 7) Physical examination and vital signs are normal or abnormal without clinical significance.;Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 5) Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical value); 6) Health: has no heart,liver, kidney, gastrointestinal tract, nervous system, respiratory system, such as asthma, exercise induced asthma, chronic obstructive pulmonary disease history; 7) Physical examination and vital signs are normal or abnormal without clinical significance.;Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 5) Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical value); 6) Health: has no heart,liver, kidney, gastrointestinal tract, nervous system, respiratory system, such as asthma, exercise induced asthma, chronic obstructive pulmonary disease history; 7) Physical examination and vital signs are normal or abnormal without clinical significance.;Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 5) Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical value); 6) Health: has no heart,liver, kidney, gastrointestinal tract, nervous system, respiratory system, such as asthma, exercise induced asthma, chronic obstructive pulmonary disease history; 7) Physical examination and vital signs are normal or abnormal without clinical significance.;Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 5) Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical value); 6) Health: has no heart,liver, kidney, gastrointestinal tract, nervous system, respiratory system, such as asthma, exercise induced asthma, chronic obstructive pulmonary disease history; 7) Physical examination and vital signs are normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1) There were more than 5 cigarette per day for three months before the trial; 2) Have a history of allergy to test drugs or their accessories, and are allergic to any kinds of medicines and food; 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 5) Any drugs that changed liver enzyme activity were taken 28 days before screening; 6) take any prescription drugs, over-the-counter medications, any vitamins or herbs within 14 days of screening; 7) Two weeks before screening, special diets (including dragon fruit, mango, grapefruit, etc.), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, or determination of nendalon; 9) There have been major changes in diet or exercise habits recently; 10) Took research drugs, or participated in clinical trials of drugs within three months prior to taking the study; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption.; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) Abnormal ecg has clinical significance or male QTCb>470ms or female QTCb> 480ms; 14) Abnormal eye examination and clinical significance including fundus examination and optical coherence tomography; 15) Female subjects were in lactation or serum pregnancy test positive during screening or study; 16) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 17) Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 18) Acute illness or adjoint medication from the screening phase to the study; 19) Ingested chocolate, any caffeinated, or flavinine-rich foods or beverages 24 hours before taking the study; 20) The alcohol breath test was positive 24 hours before or during the study; 21) Urinators or those who have used drug products in the past five years prior to the history of drug abuse or trial.;Exclusion criteria: 1) There were more than 5 cigarette per day for three months before the trial; 2) Have a history of allergy to test drugs or their accessories, and are allergic to any kinds of medicines and food; 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 5) Any drugs that changed liver enzyme activity were taken 28 days before screening; 6) take any prescription drugs, over-the-counter medications, any vitamins or herbs within 14 days of screening; 7) Two weeks before screening, special diets (including dragon fruit, mango, grapefruit, etc.), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, or determination of nendalon; 9) There have been major changes in diet or exercise habits recently; 10) Took research drugs, or participated in clinical trials of drugs within three months prior to taking the study; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption.; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) Abnormal ecg has clinical significance or male QTCb>470ms or female QTCb> 480ms; 14) Abnormal eye examination and clinical significance including fundus examination and optical coherence tomography; 15) Female subjects were in lactation or serum pregnancy test positive during screening or study; 16) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 17) Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 18) Acute illness or adjoint medication from the screening phase to the study; 19) Ingested chocolate, any caffeinated, or flavinine-rich foods or beverages 24 hours before taking the study; 20) The alcohol breath test was positive 24 hours before or during the study; 21) Urinators or those who have used drug products in the past five years prior to the history of drug abuse or trial.;Exclusion criteria: 1) There were more than 5 cigarette per day for three months before the trial; 2) Have a history of allergy to test drugs or their accessories, and are allergic to any kinds of medicines and food; 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 5) Any drugs that changed liver enzyme activity were taken 28 days before screening; 6) take any prescription drugs, over-the-counter medications, any vitamins or herbs within 14 days of screening; 7) Two weeks before screening, special diets (including dragon fruit, mango, grapefruit, etc.), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, or determination of nendalon; 9) There have been major changes in diet or exercise habits recently; 10) Took research drugs, or participated in clinical trials of drugs within three months prior to taking the study; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption.; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) Abnormal ecg has clinical significance or male QTCb>470ms or female QTCb> 480ms; 14) Abnormal eye examination and clinical significance including fundus examination and optical coherence tomography; 15) Female subjects were in lactation or serum pregnancy test positive during screening or study; 16) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 17) Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 18) Acute illness or adjoint medication from the screening phase to the study; 19) Ingested chocolate, any caffeinated, or flavinine-rich foods or beverages 24 hours before taking the study; 20) The alcohol breath test was positive 24 hours before or during the study; 21) Urinators or those who have used drug products in the past five years prior to the history of drug abuse or trial.;Exclusion criteria: 1) There were more than 5 cigarette per day for three months before the trial; 2) Have a history of allergy to test drugs or their accessories, and are allergic to any kinds of medicines and food; 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 5) Any drugs that changed liver enzyme activity were taken 28 days before screening; 6) take any prescription drugs, over-the-counter medications, any vitamins or herbs within 14 days of screening; 7) Two weeks before screening, special diets (including dragon fruit, mango, grapefruit, etc.), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, or determination of nendalon; 9) There have been major changes in diet or exercise habits recently; 10) Took research drugs, or participated in clinical trials of drugs within three months prior to taking the study; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption.; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) Abnormal ecg has clinical significance or male QTCb>470ms or female QTCb> 480ms; 14) Abnormal eye examination and clinical significance including fundus examination and optical coherence tomography; 15) Female subjects were in lactation or serum pregnancy test positive during screening or study; 16) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 17) Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 18) Acute illness or adjoint medication from the screening phase to the study; 19) Ingested chocolate, any caffeinated, or flavinine-rich foods or beverages 24 hours before taking the study; 20) The alcohol breath test was positive 24 hours before or during the study; 21) Urinators or those who have used drug products in the past five years prior to the history of drug abuse or trial.;Exclusion criteria: 1) There were more than 5 cigarette per day for three months before the trial; 2) Have a history of allergy to test drugs or their accessories, and are allergic to any kinds of medicines and food; 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 5) Any drugs that changed liver enzyme activity were taken 28 days before screening; 6) take any prescription drugs, over-the-counter medications, any vitamins or herbs within 14 days of screening; 7) Two weeks before screening, special diets (including dragon fruit, mango, grapefruit, etc.), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, or determination of nendalon; 9) There have been major changes in diet or exercise habits recently; 10) Took research drugs, or participated in clinical trials of drugs within three months prior to taking the study; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption.; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) Abnormal ecg has clinical significance or male QTCb>470ms or female QTCb> 480ms; 14) Abnormal eye examination and clinical significance including fundus examination and optical coherence tomography; 15) Female subjects were in lactation or serum pregnancy test positive during screening or study; 16) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 17) Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 18) Acute illness or adjoint medication from the screening phase to the study; 19) Ingested chocolate, any caffeinated, or flavinine-rich foods or beverages 24 hours before taking the study; 20) The alcohol breath test was positive 24 hours before or during the study; 21) Urinators or those who have used drug products in the past five years prior to the history of drug abuse or trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance, pharmacokinetics, pharmacodynamics; | — |
Countries
China
Contacts
Public ContactLan Pei;Lan Pei;Lan Pei;Lan Pei;Lan Pei ;;;;
Peking Union Second Phaemaceutical Factory;Peking Union Second Phaemaceutical Factory;Peking Union Second Phaemaceutical Factory;Peking Union Second Phaemaceutical Factory;Peking Union Second Phaemaceutical Factory
Outcome results
None listed