The Purpose of the Study is to Evaluate the Safety, Toler... | NCT06536101

NCT06536101

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GIM-407	Drug	GIM-407 oral dose	GIM-407 oral dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Area Under the Curve (AUC) will be assessed	Area under the plasma concentration versus time curve	Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum Blood Concentration (Cmax) will be assessed

Eligibility Module

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.