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Healthy VolunteersPhase 1NCT07457008

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

A Phase 1 study testing The 10mg dose group, The 20mg dose group and The 30mg dose group in people with Healthy Volunteers, run by West China Second University Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
The 10mg dose group, The 20mg dose group and The 30mg dose group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
1 Jul 2021to 9 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • .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.

Who cannot join

  • . 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;
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  • . 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);
  • . 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;
  • . Lactating or pregnant females;
  • . Other conditions deemed by the investigator as rendering the subject unsuitable for participation in the trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Second University Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Tolerability and Pharmacokinetics of Ginkgolide B Injection Following Single- and Multiple-Ascending Doses in Healthy Participants

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.

Read the detailed description

This was a single-center, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study. A total of three dose groups (low, medium, and high) were planned for the multiple-dose dose-escalation safety and tolerability study, as well as the single- and multiple-dose PK study. The dose groups were 10 mg, 20 mg, and 30 mg, with a total of 36 subjects across the three groups (12 per group).

Being tested
The 10mg dose group, The 20mg dose group, The 30mg dose group, The Placebo group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The 10mg dose groupDrug

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

  • The 20mg dose groupDrug

    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.

  • The 30mg dose groupDrug

    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.

  • The Placebo groupOther

    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.

Study groups in NCT07457008
Study groupRoleWhat they receive
Ginkgolide B Dose 1ExperimentalThe 10 mg dose group: infusion once daily for 7 consecutive days
Receives: Drug: The 10mg dose group
Ginkgolide B Dose 2ExperimentalThe 20mg dose group : infusion once daily for 7 consecutive days
Receives: Drug: The 20mg dose group
Ginkgolide B Dose 3ExperimentalThe 30mg dose group : infusion once daily for 7 consecutive days
Receives: Drug: The 30mg dose group
PlaceboPlacebo comparatorThe Placebo group : infusion once daily for 7 consecutive days
Receives: Other: The Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From screening to day 15

  2. 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

    Measured: From screening to day 15

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

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

    Measured: From screening to day 8

Secondary outcomes (1)

  1. Area Under the Plasma Concentration

    Time Curve from Time Zero to Time of Last Measurable Concentration (AUC0-t) of Ginkgolide B

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Jul 2021
  3. Primary completion3 Sep 2021
  4. Study completion9 Sep 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457008
Sponsor's protocol ID
YXNZB
Status last verified
Mar 2026
First submitted
26 Feb 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing The 10mg dose group, The 20mg dose group and The 30mg dose group in people with Healthy Volunteers, run by West China Second University Hospital 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 18 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: finished, as of the sponsor's last update on 9 Mar 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AE) as assessed by CTCAE v5.0 (time frame: From screening to day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457008.

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 9 Mar 2026.

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