Phase 1 Study on Safety, Tolerability, and Pharmacokinetics of COR-1167 in Healthy Subjects and Chronic Heart Failure Patients

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of COR-1167 in both healthy subjects and those diagnosed with **chronic heart failure**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with COR-1167, which could inform future treatment strategies for chronic heart failure. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **chronic heart failure**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is a **Phase 1**, dose-escalating, randomized, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of COR-1167 in healthy subjects and those with **chronic heart failure**. The trial is structured into three parts and is expected to commence recruitment on January 30, 2024, with an estimated completion date of July 31, 2025. The study employs a double-blind methodology to ensure unbiased results, with participants randomly assigned to either the treatment or placebo group.

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 trial inclusion. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits. These visits are designed to monitor the participants' health, assess the drug's pharmacokinetics, and evaluate any adverse effects. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather data on the long-term safety and tolerability of the investigational product.

The expected duration of participant involvement will vary depending on the specific part of the study they are enrolled in, but it is anticipated to last several months. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study protocols, or withdraw consent. The trial's design and procedures are meticulously planned to ensure the collection of reliable data while prioritizing participant safety and well-being.

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 trial documentation does not include any product authorization status or details about the product's pharmaceutical form or active substances.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an initial assessment of the investigational product's safety and potential efficacy. The estimated recruitment start date is January 30, 2024, with an anticipated end date of July 31, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically focus on safety and pharmacokinetics, with preliminary efficacy data being collected. The trial will likely involve regular assessments at predetermined intervals to monitor the investigational product's effects. Data collection methods and analysis plans are expected to adhere to standard clinical trial protocols, ensuring the reliability and validity of the findings. The trial's design will facilitate the collection of data necessary to inform subsequent phases of clinical development.