Phase I Double-Blind, Randomized, Crossover Study on Pharmacokinetics and Safety of LB-0702 vs. Romiplostim in Healthy Volunteers

The primary objective of this study is to evaluate the **pharmacokinetics** (PK), **pharmacodynamics** (PD), safety, and tolerability of a single intravenous dose (1 µg/kg) of LB-0702 compared to Nplate® in healthy volunteers. This is a bioequivalence study, which is crucial for determining whether LB-0702 can be considered therapeutically equivalent to the established treatment, Nplate®. Understanding the PK and PD profiles, along with safety and tolerability, is essential for assessing the potential of LB-0702 as an alternative therapeutic option.

The clinical trial involves a study population consisting exclusively of **male** participants, as indicated by the trial data. The age range of the participants falls within the category code "3," which typically corresponds to adults aged 18 to 65 years. The trial does not include a vulnerable population, and the study is a bioequivalence study, meaning it does not focus on a specific medical condition. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. The absence of specific inclusion or exclusion criteria suggests a broad eligibility for participation, although this cannot be confirmed due to the lack of detailed information from the sponsor.

The clinical trial is designed as a **Phase I**, double-blind, single-center, randomized, crossover study. It aims to compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous dose of LB-0702 and Nplate® in healthy volunteers. The study is a bioequivalence trial, and as such, it does not target a specific medical condition. The trial is expected to commence recruitment on May 15, 2025, and is projected to conclude by September 15, 2025.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either LB-0702 or Nplate® in a crossover manner, ensuring each participant receives both treatments at different times. The study will maintain a double-blind design to prevent bias, with neither participants nor investigators aware of the treatment assignments.

Throughout the trial, follow-up visits will be scheduled to monitor the participants' response to the treatment, collect PK and PD data, and assess safety and tolerability. These visits are crucial for evaluating the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to ensure participant safety and gather concluding data.

The expected duration of participant involvement in the trial is approximately four 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 events that compromise their safety, fail to comply with study procedures, or withdraw consent. The trial's design and procedures are structured to ensure the collection of robust and reliable data while prioritizing participant safety and adherence to ethical standards.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on May 15, 2025, with an estimated completion date of September 15, 2025. Efficacy will be evaluated using specific parameters, although the exact endpoints and methods for measurement, collection, and analysis are not detailed in the provided data. The trial will adhere to standard protocols for Phase 2 studies, focusing on the assessment of efficacy in the context of the investigational treatment. The trial's design and execution will follow established clinical guidelines to ensure the reliability and validity of the efficacy assessments.