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

ConditionDelirium
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKunming Pharmaceuticals, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • gastrodin injection；placebo

    Drug

    Single-dose intravenous administration of gastrodin injection or placebo

  • gastrodin injection；placebo

    Drug

    Multiple-dose intravenous administration of gastrodin injection or placebo

Treatment groups

54 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: group 1: 600 mgExperimental treatment 1 intervention
Group B: group 2: 1200 mgExperimental treatment 1 intervention
Group C: group 3: 1800 mgExperimental treatment 1 intervention
Group D: group 4: 300 mgExperimental treatment 1 intervention
Group E: group 5: 600 mgExperimental treatment 1 intervention
Group F: group 6: 900 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

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

Secondary outcomes

1

Cmax

Time frame
Observation was continued until 24 hours after the final administration.
2

Css min

Time frame
Observation was continued until 24 hours after the final administration.
3

Css max

Time frame
Observation was continued until 24 hours after the final administration.
4

AUC0-t

Time frame
Observation was continued until 24 hours after the final administration.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kunming Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: