Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 133

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 133
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 procedures, subject selection and exclusion criteria, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some non-clinical testing may continue
even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns
or questions related to a proposed clinical trial and places the trial on a clinical hold within that 30-day time period. In such a case,
the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed
by the FDA at any time before or during clinical trials due to safety concerns or non-compliance, and may be imposed on all products within
a certain class of products. The FDA also can impose partial clinical holds, for example, prohibiting the initiation of clinical trials
for certain duration or for certain doses.

All clinical trials must be
conducted under the supervision of one or more qualified investigators in accordance with cGCP regulations. These regulations include
the requirement that all research subjects provide informed consent in writing before their participation in any clinical trial. Further,
an IRB representing each institution participating in a clinical trial must review and approve the plan for any clinical trial before
it commences at that institution, and the IRB must conduct continuing review and reapprove the study at least annually. An IRB is responsible
for protecting the rights of clinical trial subjects and considers, among other things, whether the risks to individuals participating
in the clinical trial are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding
the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must
monitor the clinical trial until completed. Each new clinical protocol and any amendments to the protocol must be submitted to the FDA
for review, and to the IRBs for approval. Protocol detail, among other things, includes the objectives of the clinical trial, testing
procedures, sublease selection and exclusion criteria, and the parameters to be used to monitor subject safety.

Human clinical trials are
typically conducted in three sequential phases that may overlap or be combined:

  Phase 1. Phase 1 includes the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in...  
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