Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 43

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 43
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. Suspension or termination of development during any phase of clinical trials can occur if it is determined
that the participants or patients are being exposed to an unacceptable health risk. Other reasons for suspension or termination may be
made by us based on evolving business objectives and/or competitive climate.

Information about certain clinical trials must
be submitted within specific timeframes to the National Institutes of Health, for public dissemination on its ClinicalTrials.gov
website.

Human Clinical Studies in Support of
an NDA 

Clinical trials involve the administration of
the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which
include, among other things, the requirement that all research subjects provide their informed consent in writing before their participation
in any clinical trial. Clinical trials are conducted under written study protocols detailing, among other things, the inclusion and exclusion
criteria, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Human clinical trials are typically conducted
in the following sequential phases, which may overlap or be combined:

    ●
    Phase 1: The drug is initially introduced into healthy human subjects
    or, in certain indications such as cancer, patients with the target disease or condition and tested for safety, dosage tolerance,
    absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine
    optimal dosage.

    ●
    Phase 2: The drug is administered to a limited patient population to
    identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases
    and to determine dosage tolerance and optimal dosage.

    ●
    Phase 3: The drug is administered to an expanded patient population,
    generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically
    evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to
    provide adequate information for the labeling of the product.

    ●
    Phase 4: Post-approval studies, which are conducted following initial
    approval, are typically conducted to gain additional experience and data from treatment of patients in the intended therapeutic indication.

21

Progress reports detailing the results of the
clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. In addition, IND
safety reports must be submitted to the FDA for any of the following: