Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANB033 in Patients with Celiac Disease

The primary objective of the study is to evaluate the **safety**, **tolerability**, **pharmacokinetics**, and **pharmacodynamics** of single and multiple doses of ANB033 in individuals with **celiac disease**. This is clinically relevant as it aims to determine the potential therapeutic effects and safety profile of ANB033, which could contribute to the management of celiac disease, a condition characterized by an immune response to gluten that can lead to significant gastrointestinal and systemic symptoms.

The clinical trial involves a total of **118 participants** diagnosed with **Celiac disease**. The study population includes both male and female subjects, encompassing an age range from **18 to 64 years**. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided by the sponsor. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Lifestyle factors such as diet, physical activity, and habits were not specified in the available data. The selection process and any additional criteria for inclusion or exclusion were not detailed by the sponsor.

The clinical trial is designed to evaluate the **safety**, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 in individuals with **celiac disease**. This study is a Phase 1 trial, which is typically the first stage of testing in human subjects and focuses on assessing the safety profile of the investigational product. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators know who is receiving the treatment or placebo, thereby minimizing bias and ensuring the reliability of the results. The estimated recruitment start date is August 1, 2025, with the trial expected to conclude by December 31, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. Throughout the trial, participants will attend regular follow-up visits to monitor their health status, assess the investigational product's effects, and collect data on pharmacokinetics and pharmacodynamics. These visits are crucial for ensuring participant safety and collecting data necessary for evaluating the investigational product's efficacy and safety.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. During this visit, final assessments will be conducted to ensure the participant's well-being and to gather any remaining data. The expected length of participant involvement will vary depending on the dosing schedule and the specific requirements of the trial protocol. Conditions that may lead to early termination from the study include adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and rights of all participants are upheld 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 study 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, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is August 1, 2025, with an anticipated end date of December 31, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to gather data on the investigational product's effects. The schedule for measuring and collecting efficacy data is not specified, but it is common in such trials to have multiple timepoints throughout the study duration to monitor changes and trends. The analysis of collected data will likely involve statistical methods appropriate for early-phase trials, focusing on identifying any initial signs of efficacy that warrant further investigation in subsequent trial phases.