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

NCT06536101 | Completed Phase 1 DMC

• 1 other identifier: GIM407-CT01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Area Under the Curve (AUC) will be assessed

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

• Maximum Blood Concentration (Cmax) will be assessed

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

Study Arms (2)

GIM-407 oral dose

EXPERIMENTAL

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

Matching placebo oral dose

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GIM-407 DRUG

GIM-407 oral dose

GIM-407 oral dose

Placebo DRUG

Matching placebo oral dose

Matching placebo oral dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgiamune Inc: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A first in human, randomized, double-blind, placebo-controlled, dose escalation study of single and multiple oral doses of GIM-407 in healthy adult participants. The study will include 3 parts, a single ascending dose (SAD) part (Part 1) and a multiple ascending dose (MAD) part (Part 2), and optional Food-effect cohorts (Part 3), which will proceed in a staggered manner with a partial overlap.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 2, 2024
• Study Start: September 2, 2024
• Primary Completion: April 5, 2025
• Study Completion: April 5, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

AU (1)