Evaluation of AMG 691 in a Phase 1 Randomized, Double-blind, Placebo-controlled Trial in Healthy Subjects and Those with Mild-to-Moderate Asthma

The primary objective of this study is to evaluate the safety and tolerability of **AMG 691** in both healthy participants and those with mild-to-moderate **asthma**. This is clinically relevant as it aims to determine the potential of AMG 691 as a therapeutic option for asthma, a chronic respiratory condition characterized by airway inflammation and hyperreactivity. Understanding the safety profile of AMG 691 is crucial for its future development and potential use in managing asthma symptoms.

The clinical trial involves a total of **36 participants** diagnosed with **asthma**. The study population includes both male and female subjects, with an age range spanning from **18 to 65 years**. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The selection criteria for the trial population have not been detailed by the sponsor.

The clinical trial is a **Phase 1**, **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the investigational product AMG 691 in both healthy participants and those with mild-to-moderate **asthma**. The trial is set to commence recruitment on April 8, 2025, and is anticipated to conclude by November 23, 2026. The study aims to assess the safety, tolerability, and pharmacokinetics of AMG 691. Participants will be randomly assigned to receive either the investigational product or a placebo, ensuring that neither the participants nor the investigators are aware of the group assignments, thus maintaining the double-blind nature of the study.

The trial will involve a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled and undergo baseline assessments before receiving the study treatment. Throughout the trial, participants will attend regular follow-up visits to monitor their health status, collect data on any adverse events, and evaluate the investigational product's effects. The end-of-study visit will mark the completion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the study's outcomes.

The expected duration of participant involvement will vary depending on the specific protocol requirements, but it is generally anticipated to last several months. 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 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 through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on April 8, 2025, with an estimated completion date of November 23, 2026. Specific efficacy parameters, such as primary and secondary endpoints, are not detailed in the available data. The trial will likely employ standard methodologies appropriate for a Phase 1 study, potentially including validated scales, laboratory tests, or other relevant instruments to measure efficacy outcomes. The absence of detailed endpoints suggests that the focus may be on initial safety and tolerability, with efficacy being a secondary consideration. The trial's design and execution will adhere to established clinical research protocols to ensure the reliability and validity of the collected data.