Evaluating the safety and effects of GIM-407 in healthy volunteers
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 testing a new drug called GIM-407 in healthy volunteers to see how safe it is and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Georgiamune Inc Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06536101 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of GIM-407 through single and multiple ascending doses in healthy volunteers. Participants will receive either GIM-407 or a placebo, allowing researchers to observe the drug's effects without the interference of disease-related factors. The study will focus on understanding how the drug is processed in the body and its potential biomarker activity. Healthy individuals will be monitored closely during the trial to ensure their well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male or female volunteers who meet specific inclusion criteria and are willing to comply with study protocols.
Not a fit: Patients with a history of diseases affecting drug metabolism or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of GIM-407, paving the way for future treatments.
How similar studies have performed: Other studies evaluating similar pharmacokinetic and safety profiles in healthy volunteers have shown success, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne, Victoria
- Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.