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

NCT07422142 | Not Yet Recruiting Phase 1

• 1 other identifier: KPC-TMS-C101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  From the initiation of the first administration of the study drug to the completion of the study follow-up .

Secondary Outcomes (10)

• Cmax

  Observation was continued until 24 hours after the final administration.

• Css min

  Observation was continued until 24 hours after the final administration.

• Css max

  Observation was continued until 24 hours after the final administration.

• AUC0-t

  Observation was continued until 24 hours after the final administration.

• AUC0-∞

  Observation was continued until 24 hours after the final administration.

Study Arms (6)

group 1: 600 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

group 2: 1200 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

group 3: 1800 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

group 4: 300 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

group 5: 600 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

group 6: 900 mg

EXPERIMENTAL

gastrodin injection or placebo

Drug: gastrodin injection；placebo

Interventions

gastrodin injection；placebo DRUG

Single-dose intravenous administration of gastrodin injection or placebo

group 1: 600 mg; group 2: 1200 mg; group 3: 1800 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy male or female subjects aged 18 to 65 years (inclusive of boundary values), with a male-to-female ratio of 1:1.
• 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) .
• 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.

You may not qualify if:

• Subjects who developed acute diseases within 2 weeks prior to screening, such as acute gastroenteritis, acute upper respiratory tract infection, acute appendicitis, etc.
• 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.
• 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.
• Subjects with an allergic diathesis (known hypersensitivity to two or more drugs) or known hypersensitivity to Gastrodin Injection and its related excipients.
• 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 .
• Subjects who cannot tolerate venipuncture, indwelling needles or have a history of trypanophobia or hematophobia.
• Subjects with special dietary requirements who are unable to comply with the unified diet.
• 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).
• Subjects who received live attenuated vaccine within 2 weeks prior to screening or require live attenuated vaccine during the trial period.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Kunming Pharmaceuticals, Inc.: lead

Study Sites (1)

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuhong Huang, MD

  The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duo Gao, bachelor

CONTACT

0871-68319868-3052; GAODUO5@kpc.com.cn

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: February 2, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)