Evaluation of Safety, Tolerability, and Pharmacokinetics of Intranasal CBT101 in Healthy Male Subjects with Neurological Disease: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of single and multiple ascending doses of CBT101 administered intranasally in healthy male subjects. This is clinically relevant as it aims to establish the foundational safety profile and pharmacokinetic parameters of CBT101, which is crucial for determining appropriate dosing regimens and ensuring patient safety in future clinical trials involving individuals with **neurological disease**.

The clinical trial involves a study population consisting exclusively of **male** participants, with an age range categorized as adults. The trial focuses on individuals with a **neurological disease**. The sponsor has not provided information regarding the total number of participants. The selection process for the trial population is not detailed, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The trial does not include a vulnerable population, and no significant inclusion or exclusion criteria have been highlighted. The sponsor has not disclosed the main objective of the trial.

The clinical trial is a **Phase 1**, **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CBT101 administered intranasally in healthy male subjects. The trial targets a **neurological disease** and is expected to commence recruitment on December 2, 2024, with an estimated completion date of December 26, 2025. The study will involve a series of structured visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will be randomly assigned to receive either the investigational product or a placebo, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the trial.

Following the initial screening, participants will undergo a series of follow-up visits to monitor safety and collect pharmacokinetic data. These visits will be scheduled at regular intervals throughout the study duration. 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 tolerability of the investigational product. The expected length of participant involvement will span the entire trial duration, from the screening visit through to the end-of-study visit. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is meticulously designed to ensure the collection of robust data while maintaining the safety and well-being of all participants.

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.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. The information does not include parameters or endpoints used to evaluate efficacy, nor does it specify the methods, schedule, or tools for measuring, collecting, and analyzing these parameters. The trial is categorized as Phase 1, with an estimated recruitment start date of December 2, 2024, and an estimated end date of December 26, 2025. Further details on efficacy assessment are not available in the provided data.