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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: GIM-407; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching placebo oral dose; Placebo	Drug: Placebo; Matching placebo oral dose
Experimental: GIM-407 oral dose; SAD: Up to 5 ascending cohorts of subjects are planned to be orally dosed MAD: Up to 4 ascending dose cohorts of subjects are planned to be orally dosed once daily for 7 consecutive days	Drug: GIM-407; GIM-407 oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Safety	Incidence of treatment emergent AEs	Baseline through Study Completion (up to Day 14)
Evaluation of Safety	Change in laboratory safety assessments from baseline	Baseline through Study Completion (up to Day 14)
Evaluation of Safety	Number of participants with clinically significant abnormal 12-lead ECG results as assessed by the investigator	Baseline through Study Completion (up to Day 14)
Evaluation of Safety	Number of participants with abnormal physical examination findings as assessed by the investigator	Baseline through Study Completion (up to Day 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) will be assessed	Area under the plasma concentration versus time curve	Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum Blood Concentration (Cmax) will be assessed	Maximum observed concentration (Cmax)	Multiple timepoints from Baseline through Study Completion (up to Day 14)

Collaborators and Investigators

• Sponsor: Georgiamune Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): April 5, 2025
• Study Completion (Actual): April 5, 2025

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GIM407-CT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No