Phase 1 Evaluation of GB-0895 Safety and Tolerability in Patients with Mild to Moderate Asthma and Single Dose in Chronic Obstructive Pulmonary Disease

The primary objective of this Phase 1 study is to evaluate the **safety** and **tolerability** of the investigational drug GB-0895 in patients with **mild to moderate asthma** and those receiving a single dose in **Chronic Obstructive Pulmonary Disease (COPD)**. Understanding the safety profile of GB-0895 is clinically relevant as it provides foundational data necessary for further clinical development and potential therapeutic use in these respiratory conditions.

The clinical trial involves a total of **46 participants** diagnosed with **mild to moderate asthma** and **Chronic Obstructive Pulmonary Disease (COPD)**. The study population includes both male and female subjects, with an age range of 18 to 65 years. Participants were selected to ensure a representative sample of individuals with the specified medical conditions. The trial includes a vulnerable population, indicating that special considerations are in place to protect these participants. Lifestyle factors such as diet, physical activity, and habits were not specified by the sponsor. The selection process and criteria were designed to ensure the safety and relevance of the study outcomes.

The clinical trial is a **Phase 1** study designed to evaluate the safety and tolerability of the investigational drug GB-0895 in patients with **mild to moderate asthma** and those with **Chronic Obstructive Pulmonary Disease (COPD)**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the investigational drug or a placebo, thereby minimizing bias. The trial is set to commence on February 20, 2024, with an estimated completion date of February 28, 2026, indicating a total duration of approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation, including medical history review and necessary diagnostic tests. Following successful screening, participants will be randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor safety, collect data on drug tolerability, and assess any adverse events. These visits are crucial for ensuring participant safety and the integrity of the data collected. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the investigational drug's effects.

The expected length of participant involvement will vary depending on the specific protocol requirements for each condition being studied. However, participants are generally expected to remain in the study for the entire duration unless specific conditions necessitate early termination. Such conditions may include the occurrence of serious adverse events, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity. The study is designed to adhere to rigorous ethical standards and regulatory requirements, ensuring that participant welfare is prioritized throughout the trial.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of 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, indicating its primary focus on safety and dosage rather than efficacy. However, preliminary efficacy assessments may still be conducted to gather initial insights. The trial is scheduled to commence recruitment on February 20, 2024, with an estimated completion date of February 28, 2026. Although specific efficacy endpoints are not detailed, typical Phase 1 trials may include exploratory assessments of **biomarker** changes or symptom improvement using validated scales or laboratory tests. Data collection and analysis will adhere to standard clinical trial protocols, ensuring rigorous and systematic evaluation of any observed effects. The trial's design will likely incorporate predefined timepoints for data collection, although these are not specified in the available information.