英文版CRF.doc

PROTOCOL NUMBER: “A Phase I, Open Label, Single Dose, Dose-Escalation Study To Evaluate the Safety and Tolerability of drug in Healthy Male Volunteers”Investigator No.Patient No.Cohort No.Patient initial_ _ _ _ _ _ _ _ _STUDY FLOW CHART / TIME AND EVENTS SCHEDULEAssessmentsScreeningDay -14BaselineDay 024 hrsDay 3Day 7Day 14Post dosingInformed ConsentXMedical HistoryXDemographics XVital SignsXXXPhysical ExaminationXXXCBC with differential and platelet counts XXSerum ChemistryAXUrinalysisXXBlood culture (clinically indicated )XBStool Exam XECGXAdministration of Study DrugDosing Per cohort Adverse EventsC, XXDXDXXDA. Sodium, Potassium, BUN, Serum Creatinine, Chloride, Bicarbonate, Calcium, Phosphorus, Glucose, Bilirubin, ALT, AST, Alkaline Phosphatase, GGT, LDHB.Blood culture will be done if clinically indicated, such as for any febrile case ( 101 oF). C. Any AEs will be followed until satisfactory resolution or medically stable. D.Phone contact with each subject for adverse events.Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Inclusion Criteria and Exclusion CriteriaInclusion CriteriaYESNO1. Male Caucasian subjects aged 18-55 years; 2. Wwithout documented chronic disease history;3. Normal whole blood count and urinalysis;4. Normal liver and kidney function;5. Normal ECG;6. Without medications in the past two weeks;7. Able to comply with the study and follow-up procedures;8. Written (signed) Informed Consent to participate in the study, and;9. Without participation in any clinical trial within 30 days. A response of NO disqualifies the subject from participation in the studyExclusion CriteriaNOYES1. concurrent treatment with following medicinal agents:l Antiacid agents;l Antibiotics;l Bismith preparation;l Tannic acid;l Medical Charcoal;l Tincture. 2. The study will exclude of households with immunosuppressed patients, food handlers, healthcare works;3. Volunteers must be tested negative for HIV, Hepatitis B and C, and have no history of gastrointestinal disease.4. Volunteers who used any prescription drugs, including antibiotics, with 14 days, or over-the-counter drugs, including herbal remedies, with 7 days will be excluded from the study.5. Administration of any investigational test article within 30 days prior to dosing the study drug. 6. Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.A response of YES disqualifies the subject from participation in the studyProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Demography:Date of birth: _ _ / _ _ / _ _ _ _ d d m m y y y ySex (Mark one) 1 Male, 2 Female Race/Ethnicity (Mark one) 1 Asian 2 Black/Non-Hispanic 3 White/Non-Hispanic 4 Native American 5 Hispanic99 Other, specify:_ Productivity statusFemale Fertility Status:Females (mark one): 1 Pre-Menarche 3 Post-Menopausal 2 Sterile 4 Potentially able to bear childrenProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Concomitant MedicationsAre any medications used at present? 1 No 2 Yes, please record in “Concomitant Medication form” Allergy HistoryDoes the subject have any allergy history? 1 No 2 Yes, document below _Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Medical HistorySystem No.Body system Any significant medical history?If “Yes” please give detailsYesNo1.Skin102.Head, Eyes, Ears, Nose, throat103.Respiratory104.Cardiovascular105.Gastrointestinal106.Endocrine/Metabolic107.Genitourinary 108.Neurological 109.Blood/Lymphatic1010.Musculoskeletal 1011.hepatic1012.Allergies1013.Psychological/Psychiatric 1099.Other, specify:_10Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Clinical Laboratory values:Hematology Date of specimen collection: _/_/_ dd mm yyyyReference Laboratory: _ Time of specimen Collection; _ _: _ _ 24 hr. ClockTest Unit Unit(if different) Result not available ValueIs Abnormal Value clinical Significant? YesNoRBC (x106/mm3)1_ _ _. _ _10HGB (g/dL)1_ _ _. _ _10PlateletsPLT(x103/mm3)1_ _ _. _ _10HCT (%)1_ _ _. _ _10WBC (x103/mm3)1_ _ _. _ _10Differential:Polys (%)1_ _ _. _ _10Lymphocytes(%)1_ _ _. _ _10Segmented Neutrophils (%)1_ _ _. _ _10BandNeutrophils(%)1_ _ _. _ _10Monocytes(%)1_ _ _. _ _10Eosinophils (%)1_ _ _. _ _10Basophils(%)1_ _ _. _ _10If abnormal lab value is considered to be clinically significant, please indicate on the Medical HistoryProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Clinical Laboratory values:Blood Chemistry Date of specimen collection: _/_/_ dd mm yyyyReference Laboratory: _Time of specimen Collection; _ _: _ _ 24 hr. ClockTest Unit Unit(if different) Result not available ValueIs Abnormal Value clinical Significant? YesNoCalcium(mg/dL)1_ _ _. _ _10Phosphate(mg/dL)1_ _ _. _ _10Sodium(mEq/L)1_ _ _. _ _10Potassium(mEq/L)1_ _ _. _ _10Chloride(mEq/L)1_ _ _. _ _10LDH(IU/L)1_ _ _. _ _10AST(IU/L)1_ _ _. _ _10Total Bilirunbin (mg/dL)1_ _ _. _ _10ALT(IU/L)1_ _ _. _ _10ALK.Phosphatase(IU/L)1_ _ _. _ _10Total protein(g/dL)1_ _ _. _ _10Albumin(g/dL)1_ _ _. _ _10BUN(mg/dL)1_ _ _. _ _10Creatine(mg/dL)1_ _ _. _ _10Uric Acid (mg/dL)1_ _ _. _ _10If abnormal lab value is considered to be clinically significant, please indicate on the Medical HistoryProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Clinical Laboratory values:Urinalysis Date of specimen collection: _/_/_ dd mm yyyyReference Laboratory: _Time of specimen Collection; _ _: _ _ 24 hr. ClockTest Unit Unit(if different) Result not available ValueIs Abnormal Value clinical Significant? YesNoSpecific Gravity(mg/dL)1_ _ _. _ _10pH(mg/dL)1_ _ _. _ _10Color(mEq/L)1_ _ _. _ _10Appearance(mEq/L)1_ _ _. _ _10Protein (mEq/L)1_ _ _. _ _10Glucose (IU/L)1_ _ _. _ _10Ketone (IU/L)1_ _ _. _ _10If abnormal lab value is considered to be clinically significant, please indicate on the Medical HistoryProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Clinical Laboratory values:Stool analysis Date of specimen collection: _/_/_ dd mmm yyyyReference Laboratory: _Time of specimen Collection; _ _: _ _ 24 hr. ClockOva/parasite1 not done Date of assessment :_/_/_ dd mmm yyyy Results: 1 negative 2 Positive Clostridia Difficile Toxin Assay 1 not done Date of assessment :_/_/_dd mmm yyyy Results: 1 negative 2 Positive Culture for Enteric pathogens1 not done Date of assessment :_/_/_dd mmm yyyy Results: 1 negative 2 PositivePathogenResultsCampylobacter 1 negative 2 Positive Pathogenic E. Coli 1 negativeSalmonella 2 Positive Shigella 1 negativeYersina Enterocolitica 2 Positive Other 1 negative 2 Positive Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Vital Signs Visit date: _/_/_ dd mmm yyyy Temperature:_ _ _._1C 2F Blood pressure: _ / _ mmHg Systolic Diastolic Pulse:_beats per min Height: _ _ _._1cm 2inRespirations:_breaths per min Weight: _ _ _._1kg 2Ib Body surface Area:_._ _ m12-Lead ElectrocardiogramWas a 12-Lead ECG performed? 1 No 2 Yes (document below)Date and time of ECG: _/_/_ _ _ : _ _ dd mmm yyyy h h m m (00:01-23:59)Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Screening Physical Exam System No.Body system Normal Abnormal Not done Only Specify Abnormality1.Skin01972.Head, Eyes, Ears, Nose, throat01973.Respiratory01974.Cardiovascular01975.Gastrointestinal01976.Endocrine/Metabolic01977.Genitourinary 01978.Neurological 01979.Blood/Lymphatic019710.Musculoskeletal 019711.Neck019712.Breast 019713.Pelvic 019714.Rectal 019799.Other, specify:_0197Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _ScreeningVital Signs Visit date: _/_/_ dd mmm yyyy Temperature:_ _ _._1C 2F Blood pressure: _ / _ mmHg Systolic Diastolic Pulse:_beats per min Height: _ _ _._1cm 2inRespirations:_breaths per min Weight: _ _ _._1kg 2Ib Body surface Area:_._ _ mProtocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _ScreeningPhysical ExamBody code.Body system Normal Abnormal Not done Only Specify Abnormality1.Skin01972.Head, Eyes, Ears, Nose, throat01973.Respiratory01974.Cardiovascular01975.Gastrointestinal01976.Endocrine/Metabolic01977.Genitourinary 01978.Neurological 01979.Blood/Lymphatic019710.Musculoskeletal 019711.Neck019712.Breast 019713.Pelvic 019714.Rectal 019799.Other, specify:_0197- 30 -Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _ScreeningStudy Drug Administration Attach Drug Label Here1 Mark if noneDate dispensed: _/_/_ dd mmm yyyy Dispenser initials:_ _ _Dose cohorts and dose levels: 1. 630 mg 2. 1,260 mg3. 2,520 mg 4. 5,040 mgDate and time of drug administration: _/_/_ _ _ : _ _ dd mmm yyyy h h m m (00:01-23:59)Study drug compliance: No. actual taken _No. scheduled to be taken_x100=_%Does the investigator feel that the patient was complaint? 1 Yes* 0 No The 100% compliance will be required by the protocol. Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _24 hrsContact with patients though the way as below: 1 by phone 2 Clinic visit Adverse EventHas the subject experienced any Adverse Events since last visit? 1 No 2 Yes, please record any AEs in the AEs form of the CRFs. Concomitant MedicationsWere any concomitant medications used? 1 No 2 Yes, please record in “Concomitant Medication form”Blood Culture*Culture for Enteric pathogens1 not done Date of assessment :_/_/_dd mmm yyyy Results: 1 negative 2 Positive; if positive, specify the bactieria_*Blood culture will be done if clinically indicated, such as for any febrile case (101oF). Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Day 3Contact with patients though the way as below:1. By phone 2. Clinic visit Adverse EventHas the subject experienced any Adverse Events since last visit? 1 No 2 Yes, please record any AEs in the AEs form of the CRFs. Concomitant MedicationsWere any concomitant medications used? 1 No 2 Yes, please record in “Concomitant Medication form”Blood Culture*Culture for Enteric pathogens1 not done Date of assessment :_/_/_dd mmm yyyy Results: 1 negative 2 Positive; if positive, specify the bacteria_*Blood culture will be done if clinically indicated, such as for any febrile case (101oF). Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Day 7Contact with patients though the way as below:1. By phone 2. Clinic visit Adverse EventHas the subject experienced any Adverse Events since last visit? 1 No 2 Yes, please record any AEs in the AEs form of the CRFs. Concomitant MedicationsWere any concomitant medications used? 1 No 2 Yes, please record in “Concomitant Medication form”Blood Culture*Culture for Enteric pathogens1 not done Date of assessment :_/_/_dd mmm yyyy Results: 1 negative 2 Positive; if positive, specify the bacteria_*Blood culture will be done if clinically indicated, such as for any febrile case (101oF). Protocol No.Investigator No.Cohort No. Patient No.Patient initialVisit_ _ _Day 7Clinical Laboratory values:Hematology Date of specimen collection: _/_/_ dd mm yyyyReference Laboratory: _ Time of specimen Collection; _ _: _ _ 24 hr. ClockTestUnitUnit(if different)Result notavailableValueIs Abnormal Value clinical Significant?YesNoRBC (x106/mm3)1_ _ _. _ _10HGB (g/dL)1_ _ _. _ _10PlateletsPLT(x103/mm3)1_ _ _. _ _10HCT (%)1_ _ _. _ _10WBC (x103/mm3)1_ _ _. _ _10Differential:Polys (%)1_ _ _. _ _10Lymphocytes(%)1_ _ _. _ _10Segmented Neutrophils (%)1_ _ _. _ _10BandNeutrophils(%)1_ _ _. _ _10Monocytes(%)1_ _ _. _ _10Eosinophils (%)1_ _ _. _ _10Basophils(%)1_ _ _. _ _10If abnormal lab value is considered to be clinically significant, please indicate on the Medical HistoryProtocol No.Investigator No.Cohort No. Patient No.Patie