This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.
Healthy subjects, aged between 18 and 45 (both ends included), both male and female;
When screening patients, male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m² (including the upper and lower limits), BMI= weight (kg)/height (m) ²;
Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the program;
Women or men of reproductive age who agree to use investigatorial-approved contraceptive methods (such as Iuds, condoms, spermicide gel plus condoms, diaphragms, etc.) throughout the trial period;
The investigator determines that the subject has a history of present disease and past disease or dysfunction affecting the clinical trial, including but not limited to diseases of the nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, metabolic disease, rheumatic disease, blood system, etc.;
Suffers from mental illness or has a history of mental illness;
Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
History of cardiovascular disease (such as heart dysfunction, coronary artery disease, cardiomyopathy, valvular heart disease, family history of congenital long QT syndrome, family history of sudden death, etc.) or ECG results showing QTcF > 450ms, or clinically significant conduction block or T wave changes;
Parallel
Single dose, AAPB by injection, intravenous drip.
DrugSubjects received a single intravenous infusion of AAPB for injection. Each dose of AAPB for injection was dissolved with 0.9% sodium chloride injection, the infusion volume was 100mL, once a day, and each time was continuously injected for 60 min±5min.
Single dose, placebo, intravenous drip.
Other interventionSubjects received a single intravenous infusion of placebo. Each dose of placebo was dissolved by 0.9% sodium chloride injection with an infusion volume of 100mL once a day for 60 min±5min each time.
Multiple dosing, AAPB for injection, intravenous drip
DrugSubjects received AAPB for injection with multiple intravenous drips. Each dose of AAPB for injection was dissolved with 0.9% sodium chloride injection, the infusion volume was 100mL, once a day, 60 min±5min each time, for 7 consecutive days.
Multiple dosing, placebo, IV drip
Other interventionSubjects received multiple intravenous doses of placebo. Each dose of placebo was dissolved by 0.9% sodium chloride injection with an infusion volume of 100mL once a day for 60 min±5min each time for 7 consecutive days.
14
Treatment groupsSee each treatment group below.
Adverse event
Incidence of Adverse Events
Serum Human chorionic gonadotropin in female subjects of reproductive age
Maximum plasma concentration (Cmax)
Blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 90min, 120min, 180min, 240min (4h), 480min (8h），720min (12h)，1440min(24h).
Time to maximum plasma concentration (Tmax)
Blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 90min, 120min, 180min, 240min (4h), 480min (8h），720min (12h)，1440min(24h).
Elimination half-life (t1/2)
Blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 90min, 120min, 180min, 240min (4h), 480min (8h），720min (12h)，1440min(24h).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
