Phase I Evaluation of MBF-362 Safety and Tolerability in Healthy Females and Efficacy in Primary Dysmenorrhea Patients

The primary objective of this phase I study is to assess the **safety** and **tolerability** of MBF-362 in healthy women. This is clinically relevant as it establishes the foundational safety profile of the investigational product, which is crucial before further clinical development. Additionally, the study aims to evaluate the preliminary **efficacy** of MBF-362 in otherwise healthy women diagnosed with **Primary Dysmenorrhea**. Understanding the efficacy in this context is important for determining the potential therapeutic benefits of MBF-362 in managing symptoms associated with this common gynecological condition.

The clinical trial focuses on **Primary Dysmenorrhea** and involves a study population exclusively composed of female participants. The age range of the participants falls within the category code "3," which typically corresponds to a specific age group, though the exact ages are not specified. The trial does not include male subjects, and the population is not considered vulnerable. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the **safety** and **tolerability** of MBF-362 in healthy women, as well as its preliminary efficacy in women diagnosed with **primary dysmenorrhea**. This study is a Phase I trial, which is typically the first stage in testing a new treatment in humans. The trial is structured as a randomized, double-blind, and controlled study, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The estimated duration of the trial is from July 1, 2025, to December 31, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This initial visit will involve a comprehensive assessment to ensure participants meet the necessary health standards for inclusion in the trial. Following the screening, eligible participants will be randomized into treatment groups. Throughout the study, there will be scheduled follow-up visits to monitor the participants' health, assess the treatment's effects, and collect data on any adverse events. These visits are crucial for evaluating the ongoing safety and efficacy of the treatment. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement in the trial is approximately 18 months, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study protocols, or withdraw consent. The trial's design and procedures are meticulously planned to ensure the collection of reliable data while prioritizing participant safety and well-being.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on July 1, 2025, with an estimated completion date of December 31, 2026. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methodology for measuring and analyzing efficacy parameters will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific standards to evaluate the therapeutic benefits accurately.