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.
This is a dose-increasing, randomized, double-blind, placebo-controlled, single-dose/multiple-dose phase I clinical trial evaluating the safety, tolerability and pharmacokinetics of AAPB for injection in healthy Chinese subjects. The objective of this study was to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple intravenous infusion of AAPB at different doses for 7 consecutive days, and to explore the metabolites and mass balance of AAPB for injection in vivo. It provides a research basis for exploring the efficacy and safety of AAPB for injection in the treatment of acute ischemic death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Subjects 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.
Subjects 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.
Subjects 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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Adverse event
Incidence of Adverse Events
Time frame: Simple ascending dose, follow-up visit from day 1 to day 3. Multiple Ascending Dose, follow-up visit from day 1 to day 8.
Serum Human chorionic gonadotropin in female subjects of reproductive age
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Final follow-up period(day3/day8)
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 frame: Day1~day2
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).
Time frame: Day1-day2
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).
Time frame: Day1-day2
clearance, CL
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 frame: Day1-day2
Apparent distribution volume (Vz)
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).
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Subjects 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.
Time frame: Day1-day2
Steady statetime time to maximum plasma concentration (Tmax_ss)
Day1,blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h . Day4,5,6,7,blood will be drawn from adult subjects pre-drug application(within 15 min) . Day7, blood will be drawn from adult subjects pre-drug application 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after administration.
Time frame: Day1-day2, Day4-day8
steady state minimal concentration(Cmin,ss)
Day1,blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h . Day4,5,6,7,blood will be drawn from adult subjects pre-drug application(within 15 min) . Day7, blood will be drawn from adult subjects pre-drug application 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after administration.
Time frame: Day1-day2, Day4-day8
steady state maximum concentration(Cmax,ss)
Day1,blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h . Day4,5,6,7,blood will be drawn from adult subjects pre-drug application(within 15 min) . Day7, blood will be drawn from adult subjects pre-drug application 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after administration.
Time frame: Day1-day2, Day4-day8
Fluctuation Factor (DF)
Day1,blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h . Day4,5,6,7,blood will be drawn from adult subjects pre-drug application(within 15 min) . Day7, blood will be drawn from adult subjects pre-drug application 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after administration.
Time frame: Day1-day2, Day4-day8
steady state clearance(CLss)
Day1,blood will be drawn from adult subjects pre-drug application(within 60min) and at 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h . Day4,5,6,7,blood will be drawn from adult subjects pre-drug application(within 15 min) . Day7, blood will be drawn from adult subjects pre-drug application 30min, 60min, 80min, 100min, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after administration.
Time frame: Day1-day2, Day4-day8
12-lead electrocardiogram interpretation
Heart Rate,Cardiac rhythm, ECG RR interval,ECG QRS Interval, ECG PR Interval,ECG QTcF Interval,
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Administration observation period (day1~3 /day1~8), Final follow-up period(day3/day8)
Blood pressure
Blood pressure is recorded in millimeters of mercury
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Administration observation period (day1~3 /day1~8), Final follow-up period(day3/day8)
Respiration
The unit of recording is the number of breaths per minute.
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Administration observation period (day1~3 /day1~8), Final follow-up period(day3/day8)
Heart rate
The unit of heart rate is the number of heartbeats per minute.
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Administration observation period (day1~3 /day1~8), Final follow-up period(day3/day8)
Temperature
Body temperature is recorded in degrees Celsius
Time frame: Screening period (day-14 ~ day-1),Baseline Period (day0),Administration observation period (day1~3 /day1~8), Final follow-up period(day3/day8)