CPTX2309 Safety and Tolerability in Healthy Volunteers
CPTX2309
Treatment Study
Summary
Study start date: April 9, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on testing a new drug called CPTX2309, which is being studied for the first time in humans. The study aims to understand the safety and tolerability of CPTX2309 when given to healthy adults. Researchers are interested in seeing how the body processes the drug and how it affects the body. By doing this, they hope to gather important information that could lead to future treatments for various health conditions. Participants in this study will receive CPTX2309 through an intravenous (IV) line, which means the drug will be administered directly into their bloodstream. The study involves giving different doses to see how safe the drug is and how the body reacts to it. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The main focus is to ensure the drug is safe and to gather data on its effects in the body, which will help guide further research and development.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period. * Participant is willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted. * Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309. * Note: Other protocol-defined inclusion/exclusion criteria apply
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location