A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection

NCT ID: NCT06679998

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2026-03-26

Brief 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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single administration of-AAPB-10mg group

10mg of AAPB for injection was administered as a single intravenous drip

Group Type: EXPERIMENTAL

Single dose, AAPB by injection, intravenous drip.

Intervention Type: 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 -10mg group

10mg of placebo was administered as a single intravenous infusion

Group Type: PLACEBO_COMPARATOR

Single dose, placebo, intravenous drip.

Intervention Type: 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.

Single administration of -AAPB-25mg group

25mg AAPB for injection.The drug was administered as a single intravenous drip

Group Type: EXPERIMENTAL

Single dose, AAPB by injection, intravenous drip.

Intervention Type: 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 -25mg group

25mg of placebo was administered as a single intravenous infusion

Group Type: PLACEBO_COMPARATOR

Single dose, placebo, intravenous drip.

Intervention Type: 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.

Single administration of -AAPB-50mg group

50mg AAPB for injection.The drug was administered as a single intravenous drip

Group Type: EXPERIMENTAL

Single dose, AAPB by injection, intravenous drip.

Intervention Type: 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 -50mg group

50mg of placebo was administered as a single intravenous infusion

Group Type: PLACEBO_COMPARATOR

Single dose, placebo, intravenous drip.

Intervention Type: 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.

Single administration of -AAPB-75mg group

75mg AAPB for injection.The drug was administered as a single intravenous drip

Group Type: EXPERIMENTAL

Single dose, AAPB by injection, intravenous drip.

Intervention Type: 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 -75mg group

75mg of placebo was administered as a single intravenous infusion

Group Type: PLACEBO_COMPARATOR

Single dose, placebo, intravenous drip.

Intervention Type: 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.

Single administration of-AAPB-100mg group

100mg AAPB for injection.The drug was administered as a single intravenous drip

Group Type: EXPERIMENTAL

Single dose, AAPB by injection, intravenous drip.

Intervention Type: 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 -100mg group

100mg of placebo was administered as a single intravenous infusion

Group Type: PLACEBO_COMPARATOR

Single dose, placebo, intravenous drip.

Intervention Type: 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 administration-AAPB-A group for injection

AAPB-A group dose for injection An intravenous drip. Once a day for 7 days

Group Type: EXPERIMENTAL

Multiple dosing, AAPB for injection, intravenous drip

Intervention Type: DRUG

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-A group

Placebo, Group A dose, Intravenous infusion, Once a day for 7 days

Group Type: PLACEBO_COMPARATOR

Multiple dosing, placebo, IV drip

Intervention Type: OTHER

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.

Multiple administration-AAPB-B group for injection

AAPB-B group dose for injection An intravenous drip. Once a day for 7 days

Group Type: EXPERIMENTAL

Multiple dosing, AAPB for injection, intravenous drip

Intervention Type: DRUG

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-B group

Placebo, Group B dose, Intravenous infusion, Once a day for 7 days

Group Type: PLACEBO_COMPARATOR

Multiple dosing, placebo, IV drip

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Multiple dosing, AAPB for injection, intravenous drip

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.

Intervention Type: DRUG

Multiple dosing, placebo, IV drip

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects, aged between 18 and 45 (both ends included), both male and female;

2. 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;

3. Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the program;

4. 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;

5. 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.

Exclusion Criteria

1. 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.;

2. Suffers from mental illness or has a history of mental illness;

3. Have a history of malignant tumors or other diseases that are not suitable for clinical trials;

4. 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;

5. Abnormal liver function (ALT, AST higher than the upper limit of normal reference value);

6. 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;

7. Participated in any clinical trials within 3 months before enrollment;

8. Those who have special requirements for food and cannot comply with a unified diet;

9. 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;

10. Known allergic history of test drug ingredients or similar drugs, allergic disease history or allergic constitution;

11. 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;

12. 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;

13. 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);

14. Complete physical examination, vital signs, laboratory examination, ECG examination determined by the investigator to be abnormal and clinically significant;

15. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-AB), Treponema pallidum antibody (TP-Ab) any of the positive results;

16. 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;

17. Study blood donation or blood loss ≥200ml within 3 months before drug administration, or have a history of blood product use;

18. 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;

19. Persons directly related to the clinical trial;

20. Patients who cannot tolerate venipunction and have a history of fainting needles and fainting blood;

21. Other subjects deemed unsuitable for this study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Kanion Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li shuya Director of Clinical Trial Center

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhao binjiang Director of Clinical Research

Role: CONTACT

zbj0601@kanion.com

+86 15300025287

Facility Contacts

Li shuya Director of the clinical Trial Center

Role: primary

shuyali85@163.com

+86 13601367028

Other Identifiers

AAPB-Ⅰ-KY001

Identifier Type: -

Identifier Source: org_study_id