Evaluation of ENX-104 in a Single Ascending Dose Study for Patients with Major Depressive Disorder

The primary objective of this study is to evaluate the safety and tolerability of **ENX-104** in individuals diagnosed with **Major Depressive Disorder**. This is clinically relevant as it aims to determine the potential of ENX-104 as a therapeutic option for patients suffering from this condition, which is characterized by persistent feelings of sadness and loss of interest, significantly impacting daily functioning. The study will assess the effects of a single ascending dose to establish a safety profile and identify any adverse reactions associated with the treatment.

The clinical trial focuses on individuals diagnosed with **Major Depressive Disorder**. The study population includes both male and female participants, with an age range categorized under code "3", which typically represents adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed. The selection process for the trial population remains unspecified.

The clinical trial is designed to evaluate the safety and tolerability of a single ascending dose of ENX-104 in participants diagnosed with **Major Depressive Disorder**. This study is a Phase 1 trial, characterized by a randomized, double-blind, and controlled design, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thus minimizing bias. The trial is scheduled to commence recruitment on July 16, 2024, with an estimated completion date of December 25, 2024, indicating an overall trial duration of approximately five months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed to confirm participation suitability. Following successful screening, participants will be enrolled and randomized into the study. Subsequent visits will be scheduled to monitor the participants' response to the investigational product and to collect data on safety and efficacy. These follow-up visits are critical for assessing the primary and secondary endpoints of the trial. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments are conducted to ensure participant safety and to gather comprehensive data for analysis.

The expected length of participant involvement in the study is contingent upon the dosing schedule and follow-up period, typically spanning several weeks. However, certain conditions may necessitate early termination from the study, such as adverse events, withdrawal of consent, or non-compliance with study procedures. These conditions are predefined in the study protocol to ensure participant safety and data integrity. The trial's methodology and design are structured to provide robust and reliable data on the investigational product's safety profile, contributing to the understanding of its potential therapeutic benefits for individuals with Major Depressive Disorder.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

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 set for July 16, 2024, with an anticipated end date of December 25, 2024. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of pharmacokinetics and pharmacodynamics, which may include measuring **biomarker** levels or other relevant physiological responses. The trial will adhere to a predefined schedule for data collection and analysis, ensuring systematic evaluation of the investigational product's effects. The methodology will likely involve validated scales or laboratory tests, consistent with standard practices in early-phase clinical trials. The absence of detailed endpoints suggests a focus on exploratory outcomes, which will inform subsequent phases of research.