Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 188

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 188
---
 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 product and provide    
 an adequate basis for product labeling. In biologics for rare diseases where patient populations are small and there is an urgent need       
 for treatment, Phase 3 trials might not be required if an adequate risk/benefit can be demonstrated by the Phase 2 trial.                    |

113 Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. During all phases of clinical development, the FDA requires extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the