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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06536101




Registration number
NCT06536101
Ethics application status
Date submitted
26/07/2024
Date registered
2/08/2024
Date last updated
19/09/2024

Titles & IDs
Public title
The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407
Scientific 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
Secondary ID [1] 0 0
GIM407-CT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GIM-407
Treatment: Drugs - Placebo

Experimental: GIM-407 oral dose - SAD: 4 cohorts of subjects are planned to be orally dosed, ranging from 20 mg to 160 mg

MAD: 4 cohorts of subjects are planned to be orally dosed once daily for 7 consecutive days, ranging from 20 mg to 160 mg

Placebo comparator: Matching placebo oral dose - Placebo


Treatment: Drugs: GIM-407
GIM-407 oral dose

Treatment: Drugs: Placebo
Matching placebo oral dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of Safety
Timepoint [1] 0 0
Baseline through Study Completion (up to Day 14)
Primary outcome [2] 0 0
Evaluation of Safety
Timepoint [2] 0 0
Baseline through Study Completion (up to Day 14)
Primary outcome [3] 0 0
Evaluation of Safety
Timepoint [3] 0 0
Baseline through Study Completion (up to Day 14)
Primary outcome [4] 0 0
Evaluation of Safety
Timepoint [4] 0 0
Baseline through Study Completion (up to Day 14)
Secondary outcome [1] 0 0
Area Under the Curve (AUC) will be assessed
Timepoint [1] 0 0
Multiple timepoints from Baseline through Study Completion (up to Day 14)
Secondary outcome [2] 0 0
Maximum Plasma Concentration (Cmax) will be assessed
Timepoint [2] 0 0
Multiple timepoints from Baseline through Study Completion (up to Day 14)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Georgiamune Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06536101
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06536101