Pharmacokinetic Comparison of MAB-22 and Prolia® (EU and US) in Healthy Male Volunteers: A Randomized, Double-Blind, Controlled, Parallel-Group Study

The primary objective of this study is to evaluate the **pharmacokinetic** similarity of MAB-22 compared to Prolia® sourced from the European Union and the United States in healthy male participants. This is clinically relevant as it aims to establish whether MAB-22 can be considered a viable alternative to Prolia® in terms of its absorption, distribution, metabolism, and excretion characteristics. Understanding these similarities is crucial for ensuring the safety and efficacy of MAB-22 as a potential therapeutic option.

The clinical trial involves **healthy volunteers** as the study population. The participants are exclusively male, with an age range corresponding to category code 3, which typically includes adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection of the trial population does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized**, **double-blind**, controlled, parallel-group, single-dose study involving three arms. The primary aim is to compare the pharmacokinetic similarity of MAB-22 versus Prolia® sourced from the European Union and the United States in healthy male participants. The trial is categorized as a Phase 2 study and is expected to commence recruitment on May 8, 2024, with an estimated completion date of May 23, 2025. The study will involve healthy volunteers, and the trial duration is approximately one year.

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 to ensure participants meet the necessary health standards for inclusion. Following successful screening, participants will be randomized into one of the three study arms. The trial will include several follow-up visits to monitor the pharmacokinetic parameters and ensure participant safety. These visits will be scheduled at specific intervals throughout the study duration to collect necessary data and assess any adverse events.

The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the study's primary and secondary endpoints. The expected length of participant involvement will vary depending on the specific arm and schedule of follow-up visits, but it is anticipated to last several months. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events that compromise participant safety, or withdrawal of consent by the participant. The study is structured to ensure rigorous adherence to scientific and ethical standards, with all procedures conducted in accordance with regulatory guidelines.

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 2 study. The trial is scheduled to commence recruitment on May 8, 2024, with an estimated completion date of May 23, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments. The study will be conducted in accordance with regulatory requirements and ethical guidelines to ensure the integrity of the data collected.