Clinical trial NCT06536101: The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Georgiamune Inc
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of Safety
timeFrame: Baseline through Study Completion (up to Day 14)
measure: Evaluation of Safety
timeFrame: Baseline through Study Completion (up to Day 14)
measure: Evaluation of Safety
timeFrame: Baseline through Study Completion (up to Day 14)
measure: Evaluation of Safety
timeFrame: Baseline through Study Completion (up to Day 14)
Secondary outcomes:
measure: Area Under the Curve (AUC) will be assessed
timeFrame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
measure: Maximum Blood Concentration (Cmax) will be assessed
timeFrame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
Study officials:
References: