None
Conditions
Interventions
Single Ascending Doses Group 0.25mg/kg:Admission on D-1, Single Dose on D1, Followed by 6 days observation period
Single Ascending Doses Group 1mg/kg:Admission on D-1, Single Dose on D1, Followed by 6 days observation period
Single Ascending Doses Group 2mg/kg:Admission on D-1, Single Dose on D1, Followed by 6 days observation period
Single Ascending Doses Group 4mg/kg:Admission on D-1, Single Dose on D1, Followed by 6 days observation period
Single Ascending Doses Group 8mg/kg:Admission on D-1, Single Dose on D1, Followed by 6 days observation period
Single Ascending Doses Group 12mg/kg:Admission on D-1, Single Dose on D1, followed by 6 days observation period
Multiple Ascending Doses Group 2mg/kg:Admission on D-1, Dose on D1, D3, D5, D7, D9, D11, D13 (dose every 48 hrs, 7 doses), followed by 9 days observation perod in which discharge on D18 and back for f
Multiple Ascending Doses Group 4mg/kg:Admission on D-1, Dose on D1, D3, D5, D7, D9, D11, D13 (dose every 48 hrs, 7 doses), followed by 9 days observation perod in which discharge on D18 and back for f
Multiple Ascending Doses Group 8mg/kg:Admission on D-1, Dose on D1, D3, D5, D7, D9, D11, D13 (dose every 48 hrs, 7 doses), followed by 9 days observation perod in which discharge on D18 and back for f
Sponsors
Huahshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) The subject, at the time of signing the informed consent is 18-45 years old (including the boundary value at both ends); (2) Male subjects weigh >= 50 kg, female subjects weigh >= 45 kg, and both <=100 kg; Body mass index (BMI, calculation formula: BMI = weight/height square, unit: kg/m^2) within the range of 19.0-28.0 kg/m2 (including the boundary values at both ends); (3) Medical history, physical examination, electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine), chest radiograph and other results, no clinically significant abnormalities were found after evaluation by researchers; (4) The subject must guarantee and agree to be childfree and voluntarily use effective contraceptive methods within 90 days from the signing of the informed consent to the last dose (see Appendix 2 for contraceptive methods). (5) Those who have fully understood the study, voluntarily participated in it, and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Have any clear history of food and drug allergies, especially glycopeptide antibiotics; or those who, in the judgment of the investigator, may be allergic to SM-V-61 or any component of SM-V-61; (2) History or family history of severe hearing loss; (3) Cardiovascular, respiratory, digestive, endocrine, urinary, metabolic, neurological, dermatologic, ophthalmic, infectious and psychiatric diseases or abnormalities that have been or are currently clinically likely to affect the results of the trial; (4) Those who have been vaccinated (attenuated) live vaccines within 4 weeks before screening, or plan to be vaccinated (attenuated) during the trial; (5) Those who have been infected (including chronic or local infection) within 14 days before screening, or those who have a history of repeated infections and underlying diseases that are prone to infection, or those who have a history of opportunistic infections; (6) Have taken any medications, including prescription drugs, over-the-counter drugs, and herbal medicines, within 4 weeks prior to the use of the investigational drug; or use of over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks; (7) Participated in other clinical trials and received the investigational drug within 3 months before participating in this trial screening or within 5 elimination half-lives of the drug (whichever is longer); (8) Those who have lost blood or donated more than 400 mL of blood within 3 months prior to participating in this trial; or those who have received blood transfusion within 8 weeks, except for menstrual bleeding in women; (9) History of alcoholism. Drinking more than 14 standard units of alcohol per week in the past 1 year (1 standard alcohol unit is approximately equivalent to 250ml of beer with an alcohol concentration of 5%; or 12.5% alcohol by volume 100ml; or 42% alcohol by volume 30ml); (10) Those who have a history of smoking addiction in the past (average daily smoking volume within 1 month prior to participating in the screening =5) or do not agree to prohibit smoking during the trial; (11) Previous history of drug abuse or positive urine drug screening results; (12) Subject has consumed any grapefruit-containing beverage or food within 7 days prior to screening, or the subject has refused to discontinue any grapefruit-containing beverage or food during the trial; (13) Ingestion of chocolate, any caffeine-containing, or xanthine-rich food or drink within 24 hours prior to administration of study drug; Those who do not agree to avoid the use of tobacco, alcohol or caffeinated beverages within 24 hours before and during the trial, or avoid strenuous exercise, or avoid other factors that affect the absorption, distribution, metabolism, and excretion of drugs; (14) At screening, the alcohol breath screening result > 0.0 mg/100mL; (15) During the screening period, systolic blood pressure =140 mmHg, diastolic blood pressure =90 mmHg, pulse rate > 100 or 37.5°C; (16) During the screening period, the ECG result was QTcF>450 ms; (17) Subjects who are positive for any one of hepatitis B virus surface antigen, syphilis-specific antibody (TPPA), hepatitis C antibody, and AIDS antibody (HIVAb) at screening; (18) During the screening period, AST and ALT exceeded the upper limit of the reference value range; or 1.5 times the upper limit of the range of total bilirubin over the reference value;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine blood markers;Urine routine indicators;Chemistry Test ;12-lead ECG Changes;Kidney function;Coagulation Test;Cochlear function evaluation;Vital Signs (ear temperature, blood pressure decubitus position, pulse rate);Physical Exam(skin, head and neck, include mouth, ches, abdominal, spine, limbs, nervous system, superficial lymph nodes ); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK data ;12-lead ECG changes measuring for consecitive 48 hours ; | — |
Countries
China
Contacts
Public ContactWu Xiaojie, Zhang Jing
Huahshan Hospital, Fudan University
Outcome results
None listed