Phase I Double-Blind, Randomized, Placebo-Controlled Study on Safety, Tolerability, and Pharmacokinetics of THN391 in Healthy Volunteers

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of single and multiple ascending doses of THN391 in healthy subjects. This is clinically relevant as it provides foundational data on the drug's safety profile and pharmacokinetic properties, which are essential for determining appropriate dosing regimens and ensuring patient safety in future clinical trials. No secondary objectives are specified for this study.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, specifically between 18 to 65 years. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their general health status, ensuring they are free from any significant medical conditions. Lifestyle considerations such as diet, physical activity, and habits were not specified in the available data. Key inclusion or exclusion criteria were not detailed by the sponsor.

The clinical trial is designed as a **double-blind**, **randomized**, placebo-controlled, Phase I study aimed at evaluating the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of THN391 in healthy subjects. The trial is expected to commence recruitment on May 7, 2023, and is projected to conclude by August 1, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their continued eligibility and adherence to the study protocol.

The trial will include a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. The study will involve multiple follow-up visits to monitor the participants' health status, collect pharmacokinetic data, and assess any adverse events. The end-of-study visit will mark the completion of the participant's involvement, during which final assessments will be conducted to ensure participant safety and gather concluding data.

Participants may be subject to early termination from the study if they experience significant adverse events, fail to comply with the study protocol, or withdraw consent. The study's design ensures that all procedures are conducted in a manner that maintains the integrity of the data while prioritizing participant safety. The trial's methodology and procedures are structured to provide robust data on the investigational product's safety profile and pharmacokinetic properties in a controlled environment.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration 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 this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. The absence of these details suggests that the focus is primarily on the experimental medication, although further information would be required to confirm this aspect of the trial design.

Details regarding **participant compliance monitoring** and specific **dosing schedules** are not included in the provided data. This lack of information indicates that additional documentation would be necessary to fully understand the administration and monitoring protocols within the trial.

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 May 7, 2023, and an estimated end date of August 1, 2025. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a systematic approach to collect and analyze data, ensuring that the results are scientifically valid and reliable. The study will adhere to rigorous standards typical of Phase 1 trials, focusing on initial assessments of efficacy alongside safety evaluations. The absence of specific endpoints or measurement tools in the provided data suggests that these details will be defined in the full trial protocol, which will guide the execution of efficacy assessments throughout the study duration.