Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 35

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 35
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 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 healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans,        
 the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient     
 information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled,        
 scientifically valid, Phase 2 studies. Phase 1 studies also evaluate drug metabolism,