Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 185

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 185
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ials may not recommence without FDA authorization and then only under terms authorized by the FDA.

Clinical trials may involve
the administration of the biological product candidate to healthy volunteers or subjects under the supervision of qualified investigators.
Clinical trials involving some products for certain diseases, including some rare diseases may begin with testing in patients with the
disease. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,
subject selection, and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure
a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted
to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising
the GCP requirements, including the requirement that all research subjects or his or her legal representative provide informed consent.
Further, each clinical trial must be reviewed and approved by an independent IRB, at or servicing each institution at which the clinical
trial will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether
the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The
IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal
representative and must monitor the clinical trial until completed. Additionally, some trials are overseen by an independent group of
qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee.

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

| ● | Phase                                                                                        
 1. The biological product is initially introduced into healthy human subjects and            
 tested for safety. In the case of some products for rare diseases, the initial human testing 
 is often conducted in patients.                                                              |

| ● | Phase                                                                                         
 2. The biological product is evaluated in a limited patient population to identify            
 possible adverse effects and safety risks, preliminarily evaluate the efficacy of the product 
 for specific targeted diseases, and determine dosage tolerance, optimal dosage, and dosing    
 schedule.                                                                                     |

| ● | Phase                                                                                         
 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy,              
 potency, and safety in an expanded patient population at geographically dispersed clinical    
 trial sites. These clinical trials are intended to establish the overall risk/benefit ratio   
 of the