DeliriumPhase 1NCT07422142
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects
A Phase 1 study of Delirium, run by Kunming Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- 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:
- Those who have had unprotected sexual intercourse with their partners within 14 days before screening.
- Women with positive pregnancy test results or those who are lactating.
- Women whose menstrual period is expected to occur during the drug administration and safety observation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
About this study
This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects
- Conditions
- Delirium
- Being tested
- gastrodin injection；placebo
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrodin injection；placeboDrug
Single-dose intravenous administration of gastrodin injection or placebo
gastrodin injection；placeboDrug
Multiple-dose intravenous administration of gastrodin injection or placebo
| Study group | Role | What they receive |
|---|---|---|
| group 1: 600 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
| group 2: 1200 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
| group 3: 1800 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
| group 4: 300 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
| group 5: 600 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
| group 6: 900 mg | Experimental | gastrodin injection or placebo Receives: Drug: gastrodin injection；placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: From the initiation of the first administration of the study drug to the completion of the study follow-up .
Secondary outcomes (10)
Cmax
Measured: Observation was continued until 24 hours after the final administration.
Css min
Measured: Observation was continued until 24 hours after the final administration.
Css max
Measured: Observation was continued until 24 hours after the final administration.
AUC0-t
Measured: Observation was continued until 24 hours after the final administration.
AUC0-∞
Measured: Observation was continued until 24 hours after the final administration.
Tmax
Measured: Observation was continued until 24 hours after the final administration.
T1/2
Measured: Observation was continued until 24 hours after the final administration.
MRT0-t
Measured: Observation was continued until 24 hours after the final administration.
MRT0-∞
Measured: Observation was continued until 24 hours after the final administration.
CL
Measured: Observation was continued until 24 hours after the final administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuhong Huang, MD, Principal investigator, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422142
- Sponsor's protocol ID
- KPC-TMS-C101
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07422142
- Acronym / sponsor ID
- KPC-TMS-C101
- Conditions
- Delirium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group 1: 600 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
| group 2: 1200 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
| group 3: 1800 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
| group 4: 300 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
| group 5: 600 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
| group 6: 900 mg | Experimental | Drug: gastrodin injection；placebogastrodin injection or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrodin injection；placeboSingle-dose intravenous administration of gastrodin injection or placebo | Drug | group 1: 600 mg, group 2: 1200 mg, group 3: 1800 mg |
| gastrodin injection；placeboMultiple-dose intravenous administration of gastrodin injection or placebo | Drug | group 4: 300 mg, group 5: 600 mg, group 6: 900 mg |
Primary outcome
Adverse Events
Time frame: From the initiation of the first administration of the study drug to the completion of the study follow-up .
10 secondary outcomes
Cmax
Time frame: Observation was continued until 24 hours after the final administration.
Css min
Time frame: Observation was continued until 24 hours after the final administration.
Css max
Time frame: Observation was continued until 24 hours after the final administration.
AUC0-t
Time frame: Observation was continued until 24 hours after the final administration.
AUC0-∞
Time frame: Observation was continued until 24 hours after the final administration.
Tmax
Time frame: Observation was continued until 24 hours after the final administration.
T1/2
Time frame: Observation was continued until 24 hours after the final administration.
MRT0-t
Time frame: Observation was continued until 24 hours after the final administration.
MRT0-∞
Time frame: Observation was continued until 24 hours after the final administration.
CL
Time frame: Observation was continued until 24 hours after the final administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuhong Huang, MD principal investigator
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Delirium, run by Kunming Pharmaceuticals, Inc. 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 4 inclusion and 20 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: opening soon, as of the sponsor's last update on 19 Feb 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duo Gao, bachelor (0871-68319868-3052, GAODUO5@kpc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From the initiation of the first administration of the study drug to the completion of the study follow-up .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.