The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407

Last updated: July 8, 2025
Sponsor: Georgiamune Inc
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

GIM-407

Clinical Study ID

NCT06536101
GIM407-CT01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female subjects (non childbearing or agree to use appropriateeffective birth control),

  • Nonsmoker or occasional smoker (ie, who smokes ≤10 cigarettes or equivalent oftobacco or nicotine-containing products, including vapes) per week within 30 daysprior to Screening and is able to abide by the smoking policy of the study siteduring the in house observation period.

Exclusion

Exclusion Criteria:

  • History or presence of any disease that affects drug absorption, distribution,metabolism, or excretion such as gastrointestinal dysfunction, peptic ulcer,gastrointestinal surgery, cholecystectomy, etc

  • Any current active infections, including localized infections, or any recent historyof active infections, cough, or fever within 1 week prior to study drug

  • Known history of significant multiple and/or severe allergies or has had ananaphylactic reaction or significant intolerability to prescription ornonprescription drugs or food.

  • Use of any prescribed or nonprescribed medication (including over-the-countermedications, vitamins, multivitamins, recreational drugs, dietary supplements, andherbal remedies such as St. John's Wort extract) or drugs considered likely tointerfere with the safe conduct of the study within 7 days or 5 half lives of thedrug (whichever is longer) prior to the first dose

  • Receipt of an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose. Concurrently participating in anotherclinical study, at any time during the study period, in which the participant hasbeen or will be exposed to an investigational or a non investigational intervention (drug, vaccine, or invasive medical device)

  • Have received any live vaccines (bacterial or viral) within 30 days prior to thefirst dose of IP or intend to receive a live vaccine during the study period.

  • Pregnant or breastfeeding female participant. Female participant who is planning tobecome pregnant or planning to discontinue contraceptive precautions.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 02, 2024
Estimated Completion Date:
April 05, 2025

Connect with a study center

  • Nucleus Network Pty Ltd

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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