Acute Ischemic Stroke (AIS)Phase 1AAPBNCT06679998
A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection
A Phase 1 study testing Single dose, AAPB by injection, intravenous drip. and Multiple dosing, AAPB for injection, intravenous drip in people with Acute Ischemic Stroke (AIS), run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke (AIS)
- What is being tested?
- Single dose, AAPB by injection, intravenous drip. and Multiple dosing, AAPB for injection, intravenous drip
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 26 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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/m^2 (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;
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
Who cannot join
- 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;
- Abnormal liver function (ALT, AST higher than the upper limit of normal reference value);
- Any drugs that inhibit or induce liver drug metabolism enzymes (such as: inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.) were used within 30 days before drug administration; Inhibitors 5-hydroxyserotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc. Or any prescription, over-the-counter, and herbal medicines other than those described above have been taken in the 14 days prior to drug administration;
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- Participated in any clinical trials within 3 months before enrollment;
- Those who have special requirements for food and cannot comply with a unified diet;
- People who consumed any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the study drug administration, or who do not agree to prohibit the use of any caffeine-rich food or drink during the study period;
- Known allergic history of test drug ingredients or similar drugs, allergic disease history or allergic constitution;
- Smokers who smoked more than 10 cigarettes or equivalent cigarettes per day in the 1 year prior to screening, or those who could not comply with the prohibition of smoking during the test period;
- Alcohol-addicted persons with an average weekly alcohol intake of more than 14 units (1 unit =285ml beer or 25ml spirits or 150ml wine) or positive for alcohol breath test in the year before screening;
- Persons with a history of drug or drug abuse within the year prior to screening, or who test positive for drug abuse (screening items include: morphine, THC, methamphetamine, dimethylene dioxyamphetamine, ketamine and cocaine);
- Complete physical examination, vital signs, laboratory examination, ECG examination determined by the investigator to be abnormal and clinically significant;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-AB), Treponema pallidum antibody (TP-Ab) any of the positive results;
- Women who are pregnant or nursing, or who test positive for serum HCG before trial administration, or who are unable or unwilling to use investigator-approved contraception during the study period and for 3 months after the end of the study as directed by the investigator;
- Study blood donation or blood loss ≥200ml within 3 months before drug administration, or have a history of blood product use;
- Patients with a history of surgery within 3 months prior to study administration, or who have not recovered from surgery, or who have an anticipated surgical plan during the trial period;
- Persons directly related to the clinical trial;
- Patients who cannot tolerate venipunction and have a history of fainting needles and fainting blood;
- Other subjects deemed unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Li shuya Director of the clinical Trial Center, +86 13601367028, shuyali85@163.com
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke (AIS)
- Being tested
- Single dose, AAPB by injection, intravenous drip., Single dose, placebo, intravenous drip., Multiple dosing, AAPB for injection, intravenous drip, Multiple dosing, placebo, IV drip
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose, AAPB by injection, intravenous drip.Drug
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.
Single dose, placebo, intravenous drip.Other
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.
Multiple dosing, AAPB for injection, intravenous dripDrug
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.
Multiple dosing, placebo, IV dripOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single administration of-AAPB-10mg group | Experimental | 10mg of AAPB for injection was administered as a single intravenous drip Receives: Drug: Single dose, AAPB by injection, intravenous drip. |
| Single dose - placebo -10mg group | Placebo comparator | 10mg of placebo was administered as a single intravenous infusion Receives: Other: Single dose, placebo, intravenous drip. |
| Single administration of -AAPB-25mg group | Experimental | 25mg AAPB for injection.The drug was administered as a single intravenous drip Receives: Drug: Single dose, AAPB by injection, intravenous drip. |
| Single dose - placebo -25mg group | Placebo comparator | 25mg of placebo was administered as a single intravenous infusion Receives: Other: Single dose, placebo, intravenous drip. |
| Single administration of -AAPB-50mg group | Experimental | 50mg AAPB for injection.The drug was administered as a single intravenous drip Receives: Drug: Single dose, AAPB by injection, intravenous drip. |
| Single dose - placebo -50mg group | Placebo comparator | 50mg of placebo was administered as a single intravenous infusion Receives: Other: Single dose, placebo, intravenous drip. |
| Single administration of -AAPB-75mg group | Experimental | 75mg AAPB for injection.The drug was administered as a single intravenous drip Receives: Drug: Single dose, AAPB by injection, intravenous drip. |
| Single dose - placebo -75mg group | Placebo comparator | 75mg of placebo was administered as a single intravenous infusion Receives: Other: Single dose, placebo, intravenous drip. |
| Single administration of-AAPB-100mg group | Experimental | 100mg AAPB for injection.The drug was administered as a single intravenous drip Receives: Drug: Single dose, AAPB by injection, intravenous drip. |
| Single dose - placebo -100mg group | Placebo comparator | 100mg of placebo was administered as a single intravenous infusion Receives: Other: Single dose, placebo, intravenous drip. |
| Multiple administration-AAPB-A group for injection | Experimental | AAPB-A group dose for injection An intravenous drip. Once a day for 7 days Receives: Drug: Multiple dosing, AAPB for injection, intravenous drip |
| Multiple dosing -Placebo-A group | Placebo comparator | Placebo, Group A dose, Intravenous infusion, Once a day for 7 days Receives: Other: Multiple dosing, placebo, IV drip |
| Multiple administration-AAPB-B group for injection | Experimental | AAPB-B group dose for injection An intravenous drip. Once a day for 7 days Receives: Drug: Multiple dosing, AAPB for injection, intravenous drip |
| Multiple dosing -Placebo-B group | Placebo comparator | Placebo, Group B dose, Intravenous infusion, Once a day for 7 days Receives: Other: Multiple dosing, placebo, IV drip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence of Adverse Events
Measured: Simple ascending dose, follow-up visit from day 1 to day 3. Multiple Ascending Dose, follow-up visit from day 1 to day 8.
Secondary outcomes (16)
Serum Human chorionic gonadotropin in female subjects of reproductive age
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day1-day2， Day4-day8
12-lead electrocardiogram interpretation
Heart Rate，Cardiac rhythm， ECG RR interval，ECG QRS Interval， ECG PR Interval，ECG QTcF Interval，
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start14 Nov 2024 (estimated)
- Primary completion12 Jan 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li shuya Director of Clinical Trial Center, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679998
- Sponsor's protocol ID
- AAPB-Ⅰ-KY001
- Acronym
- AAPB
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06679998
- Acronym / sponsor ID
- AAPB / AAPB-Ⅰ-KY001
- Conditions
- Acute Ischemic Stroke (AIS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (estimated)
- Primary completion
- 12 Jan 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Single administration of-AAPB-10mg group | Experimental | Drug: Single dose, AAPB by injection, intravenous drip.10mg of AAPB for injection was administered as a single intravenous drip |
| Single dose - placebo -10mg group | Placebo comparator | Other: Single dose, placebo, intravenous drip.10mg of placebo was administered as a single intravenous infusion |
| Single administration of -AAPB-25mg group | Experimental | Drug: Single dose, AAPB by injection, intravenous drip.25mg AAPB for injection.The drug was administered as a single intravenous drip |
| Single dose - placebo -25mg group | Placebo comparator | Other: Single dose, placebo, intravenous drip.25mg of placebo was administered as a single intravenous infusion |
| Single administration of -AAPB-50mg group | Experimental | Drug: Single dose, AAPB by injection, intravenous drip.50mg AAPB for injection.The drug was administered as a single intravenous drip |
| Single dose - placebo -50mg group | Placebo comparator | Other: Single dose, placebo, intravenous drip.50mg of placebo was administered as a single intravenous infusion |
| Single administration of -AAPB-75mg group | Experimental | Drug: Single dose, AAPB by injection, intravenous drip.75mg AAPB for injection.The drug was administered as a single intravenous drip |
| Single dose - placebo -75mg group | Placebo comparator | Other: Single dose, placebo, intravenous drip.75mg of placebo was administered as a single intravenous infusion |
| Single administration of-AAPB-100mg group | Experimental | Drug: Single dose, AAPB by injection, intravenous drip.100mg AAPB for injection.The drug was administered as a single intravenous drip |
| Single dose - placebo -100mg group | Placebo comparator | Other: Single dose, placebo, intravenous drip.100mg of placebo was administered as a single intravenous infusion |
| Multiple administration-AAPB-A group for injection | Experimental | Drug: Multiple dosing, AAPB for injection, intravenous dripAAPB-A group dose for injection An intravenous drip. Once a day for 7 days |
| Multiple dosing -Placebo-A group | Placebo comparator | Other: Multiple dosing, placebo, IV dripPlacebo, Group A dose, Intravenous infusion, Once a day for 7 days |
| Multiple administration-AAPB-B group for injection | Experimental | Drug: Multiple dosing, AAPB for injection, intravenous dripAAPB-B group dose for injection An intravenous drip. Once a day for 7 days |
| Multiple dosing -Placebo-B group | Placebo comparator | Other: Multiple dosing, placebo, IV dripPlacebo, Group B dose, Intravenous infusion, Once a day for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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/m^2 (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;
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
Key exclusion criteria (21 listed)
- 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;
- Abnormal liver function (ALT, AST higher than the upper limit of normal reference value);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single dose, AAPB by injection, intravenous drip.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. | Drug | Single administration of -AAPB-25mg group, Single administration of -AAPB-50mg group, Single administration of -AAPB-75mg group, Single administration of-AAPB-100mg group, Single administration of-AAPB-10mg group |
| Single dose, placebo, intravenous drip.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. | Other | Single dose - placebo -100mg group, Single dose - placebo -10mg group, Single dose - placebo -25mg group, Single dose - placebo -50mg group, Single dose - placebo -75mg group |
| Multiple dosing, AAPB for injection, intravenous dripSubjects 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. | Drug | Multiple administration-AAPB-A group for injection, Multiple administration-AAPB-B group for injection |
| Multiple dosing, placebo, IV dripSubjects 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. | Other | Multiple dosing -Placebo-A group, Multiple dosing -Placebo-B group |
Primary outcome
Adverse event
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.
Incidence of Adverse Events
16 secondary outcomes
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)
Time frame: Day1~day2
Time to maximum plasma concentration (Tmax)
Time frame: Day1-day2
Elimination half-life (t1/2)
Time frame: Day1-day2
clearance, CL
Time frame: Day1-day2
Apparent distribution volume (Vz)
Time frame: Day1-day2
Steady statetime time to maximum plasma concentration （Tmax_ss）
Time frame: Day1-day2， Day4-day8
steady state minimal concentration（Cmin,ss）
Time frame: Day1-day2， Day4-day8
steady state maximum concentration（Cmax,ss）
Time frame: Day1-day2， Day4-day8
Fluctuation Factor （DF）
Time frame: Day1-day2， Day4-day8
steady state clearance（CLss）
Time frame: Day1-day2， Day4-day8
12-lead electrocardiogram interpretation
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
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
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
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
Time frame: Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Acute Ischemic Stroke
RecruitingPhase 3
ACT-GLOBAL IA Thrombolysis(ACT-REACT-004)Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Endovascular Thrombectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li shuya Director of Clinical Trial Center principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single dose, AAPB by injection, intravenous drip. and Multiple dosing, AAPB for injection, intravenous drip in people with Acute Ischemic Stroke (AIS), run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao binjiang Director of Clinical Research (+86 15300025287, zbj0601@kanion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.