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OpenTrials
Completed

NCT Number: NCT06536101

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female subjects (non childbearing or agree to use appropriate effective birth control),
  • Nonsmoker or occasional smoker (ie, who smokes ≤10 cigarettes or equivalent of tobacco or nicotine-containing products, including vapes) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site during the in house observation period.

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 history of active infections, cough, or fever within 1 week prior to study drug
  • Known history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
  • Use of any prescribed or nonprescribed medication (including over-the-counter medications, vitamins, multivitamins, recreational drugs, dietary supplements, and herbal remedies such as St. John's Wort extract) or drugs considered likely to interfere with the safe conduct of the study within 7 days or 5 half lives of the drug (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 another clinical study, at any time during the study period, in which the participant has been 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 the first dose of IP or intend to receive a live vaccine during the study period.
  • Pregnant or breastfeeding female participant. Female participant who is planning to become pregnant or planning to discontinue contraceptive precautions.

Treatment and study plan

GIM-407

Drug

GIM-407 oral dose

Placebo

Drug

Matching placebo oral dose

Primary outcomes

  1. Evaluation of Safety

    Time frame: Baseline through Study Completion (up to Day 14)

    Incidence of treatment emergent AEs

  2. Evaluation of Safety

    Time frame: Baseline through Study Completion (up to Day 14)

    Change in laboratory safety assessments from baseline

  3. Evaluation of Safety

    Time frame: Baseline through Study Completion (up to Day 14)

    Number of participants with clinically significant abnormal 12-lead ECG results as assessed by the investigator

  4. Evaluation of Safety

    Time frame: Baseline through Study Completion (up to Day 14)

    Number of participants with abnormal physical examination findings as assessed by the investigator

Secondary outcomes

  1. Area Under the Curve (AUC) will be assessed

    Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)

    Area under the plasma concentration versus time curve

  2. Maximum Blood Concentration (Cmax) will be assessed

    Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)

    Maximum observed concentration (Cmax)

Sponsors and collaborators

Lead sponsor

Georgiamune Inc

Industry

Registry information

Official study title

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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