Evaluation of Intranasal Administration of CHF6467 in Neonatal Hypoxic-Ischemic Encephalopathy: Pharmacokinetics, Safety, and Tolerability Study

The primary objective of this study is to evaluate the **safety** and **side effects** of the drug CHF6467 when administered via the intranasal route in healthy subjects. This assessment is clinically relevant as it provides critical information on the tolerability and potential adverse reactions associated with the drug, which is essential for determining its suitability for further clinical development. Additionally, the study aims to understand how CHF6467 is absorbed, modified, and removed from the body, which is crucial for optimizing dosing regimens and ensuring effective therapeutic outcomes. The study focuses on **Neonatal Hypoxic-Ischemic Encephalopathy (HIE)**, a condition that requires careful consideration of treatment safety and pharmacokinetics in the target population.

The clinical trial focuses on **Neonatal Hypoxic-Ischemic Encephalopathy (HIE)**, involving a study population that includes both male and female subjects. The age range of participants is categorized under code "3," which typically refers to neonates or infants. The trial population is considered vulnerable, indicating that special ethical considerations are in place to protect the participants. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity. Additionally, key inclusion or exclusion criteria have not been disclosed. The selection process for the trial population has not been detailed by the sponsor.

The clinical trial is designed to evaluate the safety, side effects, and pharmacokinetics of the investigational drug CHF6467 when administered via the intranasal route in healthy subjects. This study is a **Phase 3** trial, which is typically conducted to confirm the effectiveness of a treatment, monitor side effects, and collect information that will allow the drug to be used safely. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The estimated duration of the trial is from August 17, 2025, to August 31, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either the investigational drug or a placebo. Throughout the study, there will be scheduled follow-up visits to monitor the participants' health, assess the drug's effects, and collect data on any adverse events. These visits are crucial for ensuring participant safety and the integrity of the data collected. The study will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the drug's safety and efficacy.

The expected length of participant involvement in the trial is approximately one year, from the initial screening to the end-of-study visit. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the study is terminated for any reason. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 within a Phase 3 framework. The trial is scheduled to commence recruitment on August 17, 2025, with an estimated completion date of August 31, 2026. The efficacy assessment will be conducted in accordance with the trial's objectives and endpoints, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The trial will adhere to standard methodologies for measuring, collecting, and analyzing efficacy data, consistent with Phase 3 clinical trial protocols. The trial's design and execution will ensure that efficacy assessments are conducted rigorously and systematically, although specific tools or instruments for these assessments are not mentioned in the available information.