Phase Ib Evaluation of Safety, Tolerability, and Pharmacokinetics of Subcutaneous HER-096 in Healthy Volunteers and Parkinson's Disease Patients

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of subcutaneously administered HER-096 in healthy volunteer subjects and patients with **Parkinson's Disease**. This is clinically relevant as it aims to determine the potential of HER-096 as a therapeutic option, assessing its effects and behavior in the body, which is crucial for understanding its suitability for further development in treating Parkinson's Disease.

The clinical trial involves participants diagnosed with **Parkinson’s Disease**. The study population includes both male and female subjects, with an age range spanning from young adults to older adults. The sponsor has not provided the total number of participants involved in the trial. The selection of the trial population does not include any vulnerable groups. Information regarding specific lifestyle considerations such as diet, physical activity, or habits has not been disclosed. The sponsor has not provided detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of a subcutaneously administered investigational product in healthy volunteers and patients diagnosed with **Parkinson's disease**. This study is structured as a Phase Ib trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial is anticipated to commence recruitment on October 1, 2024, and is projected to conclude by December 31, 2025, marking the overall trial duration.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled in the study and will attend scheduled follow-up visits. These visits are designed to monitor the participants' health status, assess the investigational product's effects, and ensure adherence to the study protocol. 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 investigational product's impact.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. However, conditions such as adverse reactions, non-compliance with study procedures, or withdrawal of consent may lead to early termination from the study. The trial's design and procedures are meticulously crafted to uphold scientific rigor and ensure participant safety throughout the study duration.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 1, 2024, with an estimated completion date of December 31, 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 rigorous standards typical of Phase 3 studies, ensuring that the data collected is robust and reliable for assessing the efficacy of the intervention under investigation. The trial's design will likely include validated scales, laboratory tests, or patient-reported outcomes, consistent with standard practices in clinical research, although specific tools or instruments are not mentioned. The trial's focus on efficacy assessment underscores its critical role in determining the therapeutic value of the intervention being tested.