A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects

February 12, 2026 updated by: Kunming Pharmaceuticals, Inc.
This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects must have a full understanding of the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily consent to participate as subjects, sign the informed consent form prior to the initiation of any research procedures, be capable of effective communication with investigators, and understand and comply with all requirements of the study.
  2. Healthy male or female subjects aged 18 to 65 years (inclusive of boundary values), with a male-to-female ratio of 1:1.
  3. Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg. body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive of boundary values) .
  4. Subjects must have no fertility plans during the trial period and within 3 months after the final administration, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs.

Exclusion Criteria:

  1. Subjects who developed acute diseases within 2 weeks prior to screening, such as acute gastroenteritis, acute upper respiratory tract infection, acute appendicitis, etc.
  2. Subjects with a history of any clinically severe diseases or conditions that the investigator deems may interfere with the evaluation of the safety or pharmacokinetic properties of the investigational drug, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, as well as hematological, immunological, psychiatric, and metabolic diseases.
  3. Subjects who underwent major surgery within 6 months prior to screening, or plan to undergo surgery during the study period or within 1 month after the trial completion.
  4. Subjects with an allergic diathesis (known hypersensitivity to two or more drugs) or known hypersensitivity to Gastrodin Injection and its related excipients.
  5. Subjects who donated blood within 3 months prior to screening, lost a total of ≥ 400 mL of blood due to blood donation or other causes (excluding normal menstrual blood loss in females) within 6 months prior to screening, or have a history of unexplained abnormal bleeding .
  6. Subjects who cannot tolerate venipuncture, indwelling needles or have a history of trypanophobia or hematophobia.
  7. Subjects with special dietary requirements who are unable to comply with the unified diet.
  8. Subjects who participated in other clinical trials and received investigational drugs or devices within 3 months prior to screening (Note: The end time is defined as the date of the last visit for trial discharge).
  9. Subjects who received live attenuated vaccine within 2 weeks prior to screening or require live attenuated vaccine during the trial period.
  10. Subjects who used any medications (including prescription drugs, nonprescription drugs, and Chinese herbal medicines) within 2 weeks prior to screening; Subjects who have consumed strong tea, beverages containing caffeine or alcohol or pomelos, grapefruits and their juices which affect drug metabolism, within 48 hours prior to screening.
  11. Subjects with an average daily cigarette consumption of more than 5 cigarettes within 3 months prior to screening, or those who cannot discontinue the use of any tobacco products during the trial period.
  12. Subjects with a history of drug abuse (including non-medical use of various narcotic drugs and psychotropic substances) in the past year, or those with positive results in drug abuse screening (including morphine, methamphetamine, ketamine, ecstasy, tetrahydrocannabinolic acid).
  13. Subjects with alcoholism, or those who consumed alcohol frequently within 6 months prior to screening (specifically: >14 units per week. 1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of baijiu), or those with a positive alcohol breath test result at screening, or those who cannot abstain from alcohol during the trial period.
  14. Subjects with clinically significant abnormalities in vital signs assessment, physical examination, chest X-ray (posteroanterior view), clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function), and 12-lead electrocardiogram.
  15. Subjects with positive results in any item of infectious disease screening during the screening period (including hepatitis B surface antigen, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, syphilis antibody).

  16. Other subjects deemed unsuitable for participation by the investigator.

    Female subjects should also be excluded if they meet the following conditions in addition to the above requirements:

  17. Those who have had unprotected sexual intercourse with their partners within 14 days before screening.
  18. Women with positive pregnancy test results or those who are lactating.
  19. Women whose menstrual period is expected to occur during the drug administration and safety observation period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group 1: 600 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo
Experimental: group 2: 1200 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo
Experimental: group 3: 1800 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo
Experimental: group 4: 300 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo
Experimental: group 5: 600 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo
Experimental: group 6: 900 mg
gastrodin injection or placebo
Drug: gastrodin injection；placebo
Single-dose intravenous administration of gastrodin injection or placebo
Drug: gastrodin injection；placebo
Multiple-dose intravenous administration of gastrodin injection or placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse Events
Time Frame: From the initiation of the first administration of the study drug to the completion of the study follow-up .
From the initiation of the first administration of the study drug to the completion of the study follow-up .

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cmax
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
Css min
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
Css max
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
AUC0-t
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
AUC0-∞
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
Tmax
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
T1/2
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
MRT0-t
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
MRT0-∞
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.
CL
Time Frame: Observation was continued until 24 hours after the final administration.
Observation was continued until 24 hours after the final administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kunming Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuhong Huang, MD, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPC-TMS-C101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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