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

Sponsor
Kunming Pharmaceuticals, Inc.
Study ID
NCT07422142
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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

Key Dates

First listed
Feb 19, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group 1: 600 mg
    gastrodin injection or placebo
  • Experimental: group 2: 1200 mg
    gastrodin injection or placebo
  • Experimental: group 3: 1800 mg
    gastrodin injection or placebo
  • Experimental: group 4: 300 mg
    gastrodin injection or placebo
  • Experimental: group 5: 600 mg
    gastrodin injection or placebo
  • Experimental: group 6: 900 mg
    gastrodin injection or placebo

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 . ]

Central Contacts

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