Tolerability & Pharmacokinetics of Ginkgolide B Injection: Single- and Multiple-Ascending Doses in Healthy Subjects

NCT07457008 | Completed Phase 1

• 1 other identifier: YXNZB
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of multiple intravenous infusions of Ginkgolide B Injection in healthy Chinese participants, as well as to assess the pharmacokinetic (PK) characteristics following single and multiple doses.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (AE) as assessed by CTCAE v5.0

  The incidence, severity (graded by CTCAE v5.0), and relationship to the study drug of all adverse events (AEs), serious adverse events (SAEs), and AEs leading to study discontinuation will be recorded and summarized.

  From screening to day 15

• Number of Participants with Clinically Significant Changes in Laboratory Parameters

  Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes from baseline at each post-baseline visit will be summarized

  From screening to day 15

• Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)

  Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)

  From screening to day 8

Secondary Outcomes (1)

• Area Under the Plasma Concentration

  From pre-infusion (0 hours) to 24 hours post-infusion

Other Outcomes (2)

• C max

  From pre-infusion (0 hours) to 24 hours post-infusion

• t1/2

  From pre-infusion (0 hours) to 24 hours post-infusion

Study Arms (4)

Ginkgolide B Dose 1

EXPERIMENTAL

The 10 mg dose group: infusion once daily for 7 consecutive days

Drug: The 10mg dose group

Ginkgolide B Dose 2

EXPERIMENTAL

The 20mg dose group : infusion once daily for 7 consecutive days

Drug: The 20mg dose group

Ginkgolide B Dose 3

EXPERIMENTAL

The 30mg dose group : infusion once daily for 7 consecutive days

Drug: The 30mg dose group

Placebo

PLACEBO COMPARATOR

The Placebo group : infusion once daily for 7 consecutive days

Other: The Placebo group

Interventions

The 10mg dose group DRUG

The 10mg dose group was prepared with 375ml of 0.9% sodium chloride solution to form different dosage groups, an

Ginkgolide B Dose 1

The 20mg dose group DRUG

The 20mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

Ginkgolide B Dose 2

The 30mg dose group DRUG

The 30mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

Ginkgolide B Dose 3

The Placebo group OTHER

The Placebo group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

Placebo

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 45 years (inclusive), with both males and females included;
• Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, and Body Mass Index (BMI) within the range of 19.0 to 26.0 kg/m² (inclusive of 19.0 and 26.0) (BMI = weight/height²);
• Participants have no clinically significant diseases of the cardiovascular, cerebrovascular, respiratory, renal, gastrointestinal, hepatic, metabolic, endocrine, immunological, neurological, or psychiatric systems, and are in generally good health;
• Agree to have no pregnancy plans and voluntarily take effective contraceptive measures, and no sperm or egg donation plans, during the study period and for at least 6 months after the last dose of the study drug;
• Participants fully understand the purpose, nature, methods, and possible adverse reactions of the trial, can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the Informed Consent Form.

You may not qualify if:

• History of multiple or recurrent allergies, or known allergy to the study drug or drugs of similar class;
• Suffering from coagulation dysfunction, bleeding tendency, or peptic ulcer;
• Vital signs measurements, physical examination, laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation function, virology, serum human chorionic gonadotropin, etc.), 12-lead electrocardiogram, chest X-ray (PA view), abdominal ultrasound, urine drug screening, and alcohol breath test show abnormalities that are deemed clinically significant by the investigator;
• Use of any drugs that inhibit or induce hepatic drug metabolism (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, and theophyllines) within 30 days before trial drug administration;
• Participation in another clinical drug trial within 3 months prior to screening;
• Vaccination within 1 month prior to screening, or use of any medication within 2 weeks prior to screening;
• Blood loss or blood donation (including blood components) exceeding 400 mL, or receipt of blood or blood component transfusion, within 3 months prior to screening;
• Undergone major surgery within 3 months prior to screening, or planned surgery during the study period, or undergone surgery that may affect drug absorption, distribution, metabolism, or excretion;
• History of drug abuse within 6 months prior to screening, or use of narcotics (e.g., cannabis, cocaine, phencyclidine) within 3 months prior to screening;
• Average daily smoking of more than 5 cigarettes within 3 months prior to screening;
• Regular alcohol consumption within 3 months prior to screening, defined as exceeding 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine with 12% alcohol content);
• Excessive consumption of caffeinated beverages (\>4 cups/day, 1 cup = 250 mL) within 3 months prior to screening;
• Unwillingness to abstain from using/consuming any products containing nicotine, alcohol, caffeine, or grapefruit (e.g., cigarettes, nicotine lozenges, nicotine gum, coffee, tea, cola, Red Bull, chocolate, grapefruit, etc.) from the start of screening until the end of the trial; or unwillingness to avoid strenuous exercise from 48 hours before dosing until the end of the trial;
• Inability to tolerate venipuncture or history of needle phobia or syncope upon seeing blood;
• Special dietary requirements or inability to accept a standardized diet (including items such as milk);

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Qin Yu

  China West China Second University Hospital Chengdu, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Office of Clinical Trial Institution

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: July 1, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 9, 2021
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)