Phase I Study of Single and Escalating Doses of a Novel Molecule in Healthy Volunteers for the Treatment of Post-Traumatic Stress Disorder (PTSD)

The primary objective of this study is to evaluate the safety and tolerability of a new molecule administered in a single and increasing dose to healthy volunteers. This investigation is crucial for determining the potential of the molecule as a therapeutic agent for **Post-Traumatic Stress Disorder (PTSD)**. Understanding the safety profile is essential before proceeding to further clinical trials involving patients with the condition. No secondary objectives are specified for this study.

The clinical trial focuses on **Post-Traumatic Stress Disorder (PTSD)** and involves a study population exclusively comprising male participants. The age range of the participants is categorized under code "3," which typically represents adults, although specific age details are not provided. The trial does not include a vulnerable population, and the selection criteria for participants have not been disclosed by the sponsor. Additionally, there is no information available regarding the total number of participants, as the sponsor has not provided this data. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the safety and tolerability of a new molecule intended for the treatment of **Post-Traumatic Stress Disorder (PTSD)**. This is a Phase 1 trial, which involves the first administration of a single and increasing dose in healthy volunteers. The trial follows a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is from August 1, 2023, to August 31, 2024, encompassing the recruitment and follow-up periods.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will include a comprehensive medical evaluation and baseline assessments. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. Subsequent visits will be scheduled to monitor the participants' health, collect data on the pharmacokinetics and pharmacodynamics of the investigational product, and assess any adverse events. The frequency and number of follow-up visits will be determined by the study protocol, ensuring thorough monitoring throughout the trial period.

The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall safety and any long-term effects of the investigational product. The expected length of participant involvement will vary depending on the dosing schedule and follow-up requirements, but it is anticipated to last several months. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent by the participant, or any protocol deviations that compromise the integrity of the trial. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of August 1, 2023, and an estimated end date of August 31, 2024. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve standard methodologies appropriate for a Phase 1 study. These may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy. The schedule for measuring and collecting data will be aligned with the trial's timeline, ensuring systematic data collection and analysis. The trial's efficacy assessments will be conducted in accordance with established clinical trial protocols, ensuring the reliability and validity of the results.