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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: GIM-407; Drug: Placebo

• Registration Number: NCT06536101
• Lead Sponsor: Georgiamune Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-02
• Study Start: 2024-09-02
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Study Completion: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GIM-407 oral dose	GIM-407	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
Matching placebo oral dose	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Evaluation of Safety	Baseline through Study Completion (up to Day 14)	Number of participants with abnormal physical examination findings as assessed by the investigator

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia