Phase I Double-Blind Randomized Placebo-Controlled Study on Safety and Pharmacokinetics of KAND145 in Healthy Volunteers with Ovarian Cancer

The primary objective of this Phase I, double-blind, randomized, placebo-controlled study is to investigate the **safety** and **tolerability** of the study product KAND145 in healthy volunteers. This is clinically relevant as it provides foundational data on the potential adverse effects and overall acceptability of KAND145, which is crucial before proceeding to further clinical trials involving patients with **ovarian cancer**. The study also aims to evaluate the concentrations of KAND145 in the participants, which is essential for understanding its pharmacokinetics and optimizing dosing regimens in future studies.

The clinical trial involves participants diagnosed with **ovarian cancer**. The study population includes both male and female subjects, with an age range categorized under code "3," which typically represents adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The trial population was selected without any specified key inclusion or exclusion criteria.

This clinical trial is a **Phase I**, double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, and concentrations of the investigational product KAND145 in healthy volunteers. The trial is specifically focused on **ovarian cancer**. The study is set to commence recruitment on September 30, 2023, and is expected to conclude by August 30, 2024. Participants will be randomly assigned to receive either the investigational product or a placebo, with neither the participants nor the investigators aware of the group assignments, ensuring the study's double-blind nature.

The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before the administration of the study product. Subsequent follow-up visits will be scheduled to monitor safety, tolerability, and pharmacokinetic parameters. These visits will include clinical evaluations, laboratory tests, and other relevant assessments as per the study protocol. The end-of-study visit will mark the completion of the participant's involvement, during which final evaluations will be conducted to ensure participant safety and gather comprehensive data on the investigational product's effects.

Participant involvement is expected to last for the duration of the trial, from the initial screening through to the end-of-study visit. However, conditions such as adverse events, non-compliance with the study protocol, or withdrawal of consent may lead to early termination from the study. The trial's design and procedures are structured to maintain scientific rigor while ensuring participant safety and data integrity throughout the study period.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of 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 September 30, 2023, with an anticipated end date of August 30, 2024. Although specific efficacy parameters such as primary and 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 measure changes in **biomarker** levels or symptom improvement. The schedule for measuring and collecting data is typically aligned with the trial's timeline, ensuring systematic data collection at predefined intervals. The analysis of efficacy data will be conducted using appropriate statistical methods to determine the potential therapeutic effects of the investigational product. The trial's design and methodology adhere to regulatory standards to ensure the reliability and validity of the findings.