Dose-Finding Study to Evaluate Intestinal Lactase Activity via Oral Gaxilose Administration in Healthy Adult Volunteers with Hypolactasia

The primary objective of this clinical trial is to evaluate **intestinal lactase activity** through the administration of oral gaxilose in healthy adult volunteers. This is clinically relevant as it aims to assess the potential of gaxilose in diagnosing or managing **hypolactasia**, a condition characterized by reduced lactase enzyme activity leading to lactose intolerance. Understanding the efficacy of gaxilose in this context could provide insights into non-invasive diagnostic methods or therapeutic options for individuals with lactose intolerance.

The clinical trial focuses on participants diagnosed with **hypolactasia**, a condition characterized by the inability to digest lactose properly. The study population includes both male and female subjects, with an age range spanning from children to adults. The trial does not specifically target a vulnerable population. However, the total number of participants involved in the study has not been disclosed by the sponsor. Participants were selected based on criteria that were not provided, and no specific lifestyle considerations such as diet, physical activity, or habits have been highlighted. The absence of detailed inclusion or exclusion criteria suggests that the trial may have a broad participant base, although this cannot be confirmed without additional information.

The clinical trial is designed to evaluate **intestinal lactase activity** through oral administration of gaxilose in healthy adult volunteers. This is a Phase 3, randomized, double-blind, controlled trial focusing on the condition of **hypolactasia**. The trial is set to commence recruitment on September 1, 2025, with an estimated completion date of March 1, 2026. The trial will involve a series of study visits, beginning with an inclusion visit where participants will be screened for eligibility based on predefined criteria. This initial visit will ensure that only suitable candidates are enrolled in the study.

Following the inclusion visit, participants will undergo a series of follow-up visits. These visits are structured to monitor the participants' response to the treatment and to collect necessary data for the evaluation of the primary and secondary endpoints. The sequence and frequency of these visits are designed to ensure comprehensive data collection while maintaining participant safety. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the outcomes of the trial.

The expected length of participant involvement in the trial is approximately six months, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience adverse effects, fail to comply with study protocols, or withdraw consent. The trial's methodology, including its randomized and double-blind design, aims to minimize bias and ensure the reliability of the results. The controlled nature of the trial provides a comparative framework to assess the efficacy and safety of the intervention. The trial's design and procedures are aligned with regulatory standards to ensure the integrity and scientific validity of the findings.

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 in a Phase 3 study. The trial is scheduled to commence recruitment on September 1, 2025, with an estimated completion date of March 1, 2026. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on the evaluation of treatment effects in a larger patient population. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.