Cardiovascular Safety Evaluation of CHF6001 (Tanimilast) Administered via NEXThaler® in Healthy Adult Volunteers: A Phase I Study

The primary objective of this Phase I study is to evaluate the **cardiovascular safety** of CHF6001 (Tanimilast) when administered using the NEXThaler® device in healthy adult volunteers. The study focuses on assessing the effect of Tanimilast on heart rate (HR) and its safety profile through electrocardiographic monitoring, including the analysis of QT and QTc intervals. This evaluation is clinically relevant as it helps determine the potential cardiovascular risks associated with Tanimilast, ensuring its safe use in future therapeutic applications.

The clinical trial involves **healthy adult volunteers** to assess the cardiovascular safety of CHF6001 (Tanimilast) administered with the NEXThaler® device. The study population includes both male and female participants, with an age range classified under category code 3, which typically represents adults. The trial does not specify the total number of participants, as the sponsor has not provided this information. Participants were selected based on their general health status, ensuring they are free from significant medical conditions that could affect the study's outcomes. Lifestyle considerations such as diet, physical activity, and habits are not detailed in the available data. The trial includes a vulnerable population, indicating that special ethical considerations are in place to protect these participants. Key inclusion or exclusion criteria are not specified in the provided information.

The clinical trial is a **Phase I** study designed to evaluate the cardiovascular safety of CHF6001 (Tanimilast) when administered using the NEXThaler® device in healthy adult volunteers. The primary focus is on assessing the effect on heart rate and cardiovascular safety through electrocardiographic monitoring, including QT and QTc intervals. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The estimated duration of the trial spans from the recruitment start date on August 7, 2025, to the anticipated end date on March 18, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment, including medical history, physical examination, and baseline electrocardiographic measurements. Following successful screening, participants will be randomized and commence the treatment phase. Throughout the study, follow-up visits will be scheduled at regular intervals to monitor safety parameters, adherence to the protocol, and any adverse events. These visits will include repeated electrocardiographic assessments to ensure ongoing cardiovascular safety. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to assess the overall safety and any long-term effects of the treatment.

The expected length of participant involvement is approximately seven months, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 7, 2025, with an estimated completion date of March 18, 2026. The efficacy assessment will be conducted in accordance with the trial's protocol, which is structured to ensure rigorous evaluation of the treatment's impact. The specific parameters or endpoints for evaluating efficacy have not been detailed in the available data. The trial will adhere to standard practices for data collection and analysis, ensuring that the results are scientifically valid and reliable. The trial's design and execution will follow established guidelines to maintain the integrity and accuracy of the efficacy assessments.