Safety and Tolerability Assessment of OM-85-IN in Healthy Volunteers and Patients with Mild Allergic Asthma

The primary objective of this clinical study is to evaluate the **safety** and **tolerability** of OM-85-IN in healthy volunteers and patients with mild allergic asthma. This is clinically relevant as it aims to ensure that the investigational product does not pose undue risk to participants and is well-tolerated, which is crucial for further development and potential therapeutic use in managing mild allergic asthma.

The clinical trial involves participants diagnosed with **mild allergic asthma**. The study population includes both male and female subjects, with an age range of 18 to 65 years. The trial includes a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet, physical activity, or habits are not provided. The sponsor has not disclosed the total number of participants involved in the study. Key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed to evaluate the **safety** and tolerability of OM-85-IN in healthy volunteers and patients with **mild allergic asthma**. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research focusing on assessing the safety profile of a new intervention. The trial is expected to commence recruitment on June 7, 2024, and is projected to conclude by January 31, 2025. The study employs a randomized, double-blind, controlled design to ensure unbiased results and to maintain the integrity of the data collected.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, potential participants will be assessed against the inclusion and exclusion criteria to determine their eligibility for the trial. Once enrolled, participants will attend scheduled follow-up visits, which are critical for monitoring their health status and any adverse effects that may arise from the intervention. These visits will also involve the collection of data necessary for evaluating the primary and secondary endpoints of the study. The end-of-study visit marks the final assessment of participants, where comprehensive evaluations are conducted to gather conclusive data on the intervention's safety and tolerability.

The expected duration of participant involvement in the trial is approximately seven months, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as the occurrence of significant adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the study duration.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication 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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical 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 June 7, 2024, and an estimated end date of January 31, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 1 trials typically focus on safety and dosage, with preliminary efficacy assessments often included. The trial will likely involve the collection and analysis of data at various timepoints throughout the study duration. The methods for measuring and analyzing efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design will incorporate appropriate tools and instruments to facilitate accurate efficacy assessments, although specific tools are not mentioned. The overall aim is to gather data that will inform subsequent phases of clinical research.