Evaluation of Safety, Tolerability, and Efficacy of Recombinant Chimeric Bacteriophage Endolysin HY-133 in MSSA Nasal Colonization

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **efficacy** of a recombinant chimeric bacteriophage endolysin HY-133 in individuals with nasal colonization by methicillin-susceptible **Staphylococcus aureus** (MSSA). This is clinically relevant as MSSA colonization can lead to infections, and effective treatment could reduce the risk of subsequent infection and transmission. The study is designed as a randomized, double-blind, placebo-controlled trial, including both single-dose and multiple-dose phases, to comprehensively assess the therapeutic potential of HY-133.

The clinical trial involves participants with **nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)**. The study population includes both male and female subjects, with an age range that spans from children to adults. The trial specifically includes vulnerable populations, although the exact number of participants has not been disclosed by the sponsor. Participants were selected based on their health status related to the specified medical condition. Lifestyle considerations such as diet, physical activity, or habits have not been detailed. The sponsor has not provided specific information regarding the total number of participants or the key inclusion or exclusion criteria for this trial.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** study to assess the safety, tolerability, and efficacy of a recombinant chimeric bacteriophage endolysin HY-133. The trial will focus on individuals with **nasal colonization with methicillin-susceptible Staphylococcus aureus (MSSA)**. The study is structured to include both single-dose and multiple-dose phases, with an extended phase to evaluate the effects on the nasal microbiome. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of July 1, 2024, and an anticipated end date of July 31, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. The sequence of study visits will include initial dosing visits, subsequent follow-up visits to monitor safety and efficacy, and an end-of-study visit to conclude participation. The expected duration of participant involvement will be determined by the dosing schedule and follow-up requirements, with specific timelines provided to participants upon enrollment.

Conditions that may lead to early termination from the study include adverse events that compromise participant safety, non-compliance with study procedures, or withdrawal of consent. The trial will adhere to rigorous methodological standards to ensure the integrity of the data collected and the safety of all participants. The study's design and procedures are aligned with ethical guidelines and regulatory requirements to facilitate a comprehensive evaluation of the investigational product's potential benefits and risks.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, it is not possible to provide further details about the **active substances** or the **pharmaceutical form** of the products involved in the trial. The trial documentation does not include any product names, sponsor product codes, or information about the origin of the active substances. Consequently, the description of the treatments used in this clinical trial remains limited to the general framework outlined above.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is July 1, 2024, with an anticipated end date of July 31, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of therapeutic effects alongside safety evaluations. The trial will likely employ standardized methods for measuring and collecting data, which may include validated scales, laboratory tests, or patient-reported outcomes, depending on the investigational product and condition under study. The analysis of efficacy data will be conducted in accordance with the trial's protocol, ensuring rigorous and scientifically sound evaluation of the investigational product's potential benefits.