Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 241

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 241
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 toxicity, improve metabolism, absorption and pharmacokinetic properties. • CTA-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for CTA submission. • IND-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for IND submission. • In vitro validation: At this stage, the efficacy and safety of a drug candidate are assessed at cellular levels. • In vivo validation: At this stage, the efficacy, safety and pharmacokinetic of a drug candidate are assessed in animal models. • IND Preparation and Submission: Preparation of a package of documents for different sections such as CMC, clinical, nonclinical, etc. and getting them reviewed, approved and final checked and followed by submission to regulatory agencies. 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 Phase1, 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, structure -activityrelationships, and the mechanism of action in humans. These studies also determine which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of subjects included in Phase 1 studies varies with the drug, but is generally in the range of twenty to eighty. • Phase 2.Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short -termside effects and risks associated with the drug. Phase 2 studies are typically well -controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people. 121 • Phase 3.Phase 3 studies are expanded controlled and