Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 132

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 132
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 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.

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●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.

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 clinical trials must be submitted to the FDA. Written IND safety reports must be
promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings from other studies, tests
in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically important increase in
the rate of serious suspected adverse reactions over those listed in the protocol or investigator brochure. The sponsor must submit an
IND safety report within 15 calendar days after the sponsor determines that the information qualifies for such reporting. The sponsor
also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within 7 calendar days after the sponsor’s
initial receipt of the information. Phase 1, Phase