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Healthy volunteers test new Ginkgo-Based injection for safety

NCT ID NCT07457008

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and tolerability of Ginkgolide B injection in 36 healthy adults aged 18 to 45. Participants received single or multiple doses to see how the drug behaves in the body and what side effects occur. The goal was to gather safety data, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

36 people

The number who actually took part.

Started

Jul 2021

Finished

Sep 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. .Aged 18 to 45 years (inclusive), with both males and females included; 2. .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); 3. .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; 4. .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; 5. .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. Exclusion Criteria: 1. . History of multiple or recurrent allergies, or known allergy to the study drug or drugs of similar class; 2. . Suffering from coagulation dysfunction, bleeding tendency, or peptic ulcer; 3. . 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; 4. . 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; 5. . Participation in another clinical drug trial within 3 months prior to screening; 6. . Vaccination within 1 month prior to screening, or use of any medication within 2 weeks prior to screening; 7. . 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; 8. . 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; 9. . 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; 10. . Average daily smoking of more than 5 cigarettes within 3 months prior to screening; 11. . 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); 12. . Excessive consumption of caffeinated beverages (\>4 cups/day, 1 cup = 250 mL) within 3 months prior to screening; 13. . 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; 14. . Inability to tolerate venipuncture or history of needle phobia or syncope upon seeing blood; 15. . Special dietary requirements or inability to accept a standardized diet (including items such as milk); 16. . Use of long-acting estrogens, progestins, or contraceptives within 6 months prior to the trial; use of any hormones or contraceptives within 30 days prior to the trial; unprotected sexual intercourse with a partner within 14 days prior to the trial for females of childbearing potential; 17. . Lactating or pregnant females; 18. . Other conditions deemed by the investigator as rendering the subject unsuitable for participation in the trial

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • West China Second University Hospital

    Chengdu, Sichuan, 610041, China

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