Healthy Volunteers
Conditions
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.
Interventions
DRUGGIM-407
GIM-407 oral dose
DRUGPlacebo
Matching placebo oral dose
Sponsors
Georgiamune Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Safety | Baseline through Study Completion (up to Day 14) | Incidence of treatment emergent AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia
Outcome results
None listed