Healthy VolunteersPhase 1NCT06536101
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 study testing GIM-407 in people with Healthy Volunteers, run by Georgiamune Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GIM-407
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Sep 2024to 5 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- GIM-407, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIM-407Drug
GIM-407 oral dose
PlaceboDrug
Matching placebo oral dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GIM-407 |
| Matching placebo oral dose | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Incidence of treatment emergent AEs
Measured: Baseline through Study Completion (up to Day 14)
Evaluation of Safety
Change in laboratory safety assessments from baseline
Measured: 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
Measured: Baseline through Study Completion (up to Day 14)
Evaluation of Safety
Number of participants with abnormal physical examination findings as assessed by the investigator
Measured: Baseline through Study Completion (up to Day 14)
Secondary outcomes (2)
Area Under the Curve (AUC) will be assessed
Area under the plasma concentration versus time curve
Measured: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum Blood Concentration (Cmax) will be assessed
Maximum observed concentration (Cmax)
Measured: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start2 Sep 2024
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgiamune Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536101
- Sponsor's protocol ID
- GIM407-CT01
- Status last verified
- Jul 2025
- First submitted
- 26 Jul 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06536101
- Acronym / sponsor ID
- GIM407-CT01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Georgiamune IncIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GIM-407 oral dose | Experimental | Drug: GIM-407SAD: 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 comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIM-407GIM-407 oral dose | Drug | GIM-407 oral dose |
| PlaceboMatching placebo oral dose | Drug | Matching placebo oral dose |
Primary outcome
Evaluation of Safety
Time frame: Baseline through Study Completion (up to Day 14)
Incidence of treatment emergent AEs
Evaluation of Safety
Time frame: Baseline through Study Completion (up to Day 14)
Change in laboratory safety assessments from baseline
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
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
2 secondary outcomes
Area Under the Curve (AUC) will be assessed
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum Blood Concentration (Cmax) will be assessed
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GIM-407 in people with Healthy Volunteers, run by Georgiamune Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Baseline through Study Completion (up to Day 14)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.