Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 72

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 72
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 the trial, the criteria for determining subject eligibility, the dosing plan, the parameters to be used in monitoring safety, the procedure
for timely reporting of adverse events, and the efficacy criteria to be evaluated. Each protocol involving testing on U.S. patients and
subsequent protocol amendments must be submitted to the FDA as part of the IND.

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Further, an IRB representing each institution that
is participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution,
and the IRB must thereafter conduct a continuing review and re-approve the trial at least annually until completion. The IRB must review
and approve, among other things, the trial protocol and informed consent information to be provided to clinical trial subjects. An IRB
must operate in compliance with FDA regulations.

Information about certain clinical trials, including
details of the protocol and eventually study results, also must be submitted within specific time frames to the National Institutes of
Health (“NIH”), for public dissemination on the ClinicalTrials.gov data registry. Information related to the product, patient
population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the
registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure
of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Failure to
timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties
and also prevent the non-compliant party from receiving future grant funds from the federal government. The U.S. Department of Health
and Human Services’ Final Rule and NIH’s complementary policy on ClinicalTrials.gov registration and reporting requirements
became effective in 2017, and the government has brought enforcement against clinical trial sponsors that fail to comply with such requirements.

For purposes of supporting NDA submission and approval,
human clinical trials are typically conducted in the following sequential phases, which may overlap:

●Phase 1: Trials are initially conducted in a limited population of healthy human subjects to test the drug candidate for safety, dose
tolerance, absorption, metabolism, distribution, and excretion of the investigational product, the side effects associated with increasing
doses, and, if possible, to gain early evidence on effectiveness.

●Phase 2: The investigational product is administered to a limited patient population with a