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

NCT06679998 | Not Yet Recruiting Phase 1

• 1 other identifier: AAPB-Ⅰ-KY001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke (AIS)

Outcome Measures

Primary Outcomes (1)

• Adverse event

  Incidence of Adverse Events

  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

  Screening period (day-14 ~ day-1)，Baseline Period (day0)，Final follow-up period(day3/day8)

• Maximum plasma concentration (Cmax)

  Day1~day2

• Time to maximum plasma concentration (Tmax)

  Day1-day2

• Elimination half-life (t1/2)

  Day1-day2

• clearance, CL

  Day1-day2

Study Arms (14)

Single administration of-AAPB-10mg group

EXPERIMENTAL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Other: Multiple dosing, placebo, IV drip

Interventions

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 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. 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 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 drip 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 administration-AAPB-A group for injection; Multiple administration-AAPB-B group for injection

Multiple dosing, placebo, IV drip 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 dosing -Placebo-A group; Multiple dosing -Placebo-B group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Infusions, Intravenous; Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Li shuya Director of Clinical Trial Center

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao binjiang Director of Clinical Research

CONTACT

+86 15300025287; zbj0601@kanion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 8, 2024
• Study Start: November 14, 2024
• Primary Completion: January 12, 2026
• Study Completion: March 26, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CN (1)