Phase 1 Study of JNJ-95597528: Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Mechanism Proof in Mild to Moderate Asthma

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of JNJ-95597528 in healthy participants. This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human single ascending dose study. The clinical relevance of this objective lies in establishing a foundational understanding of the drug's safety profile and pharmacokinetic properties, which are critical for determining appropriate dosing regimens and ensuring patient safety in subsequent trials. Additionally, the study includes a proof of mechanism component in participants with mild to moderate **asthma**, aiming to provide preliminary insights into the drug's potential therapeutic effects in this population.

The clinical trial involves a total of **103 participants** diagnosed with **mild to moderate asthma**. The study population includes both male and female subjects, with an age range of 18 to 65 years. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided by the sponsor. The trial does not focus on a vulnerable population. General health status and lifestyle considerations such as diet, physical activity, or habits were not specified. The selection process aimed to ensure a representative sample of individuals with the specified medical condition, without targeting any particular lifestyle or demographic subgroup.

This clinical trial is a **Phase 1**, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of JNJ-95597528 in healthy participants, as well as to conduct a proof of mechanism study in participants with **mild to moderate asthma**. The trial is structured to include a single ascending dose study, with the primary aim of assessing the investigational product's initial safety profile and pharmacokinetic parameters. The trial is expected to commence recruitment on June 5, 2025, and is projected to conclude by March 28, 2027.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This initial visit will involve a comprehensive assessment to ensure participants meet the necessary health standards for trial inclusion. Following successful screening, participants will be randomized to receive either the investigational product or a placebo in a double-blind manner, ensuring that neither the participants nor the investigators are aware of the treatment allocation. Subsequent follow-up visits will be scheduled to monitor participants' health, collect pharmacokinetic data, and assess any adverse events. These visits are critical for evaluating the investigational product's safety and tolerability over time.

The end-of-study visit will mark the conclusion of each participant's involvement in the trial, during which final assessments will be conducted to gather comprehensive data on the investigational product's effects. The expected duration of participant involvement will vary depending on the dosing schedule and follow-up requirements, but it is anticipated to span several weeks. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigators to ensure participant safety.

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 through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is June 5, 2025, with an anticipated end date of March 28, 2027. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of therapeutic effects alongside safety evaluations. The trial will likely employ standardized methods for data collection and analysis, consistent with the rigorous requirements of early-phase clinical research. The absence of detailed endpoints suggests that the primary focus may be on safety and tolerability, with efficacy assessments being exploratory in nature. The trial's design will adhere to established protocols to ensure the reliability and validity of the collected data.