Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects

Launched by COMANCHE BIOPHARMA · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CBP-4888 to understand how safe it is and how the body processes it. This is the first time this medication is being tested in humans, and the study will involve giving different doses to healthy women who are not pregnant. The trial is designed to help researchers learn more about how CBP-4888 works and whether it can be tolerated well by participants.

To participate in this study, women aged between 18 and 62 who are in good health may be eligible. They need to have a specific body weight range and must not have any significant health issues. Participants will go through a series of health checks to ensure they are suitable for the study. If they qualify, they will receive either the medication or a placebo (a non-active substance that looks like the medication) in a controlled environment. Throughout the trial, participants can expect to have their health closely monitored to ensure their safety. This study is currently recruiting participants, and it is important for anyone interested to discuss it with their healthcare provider to understand more about the process and any potential risks.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy non-pregnant female subjects
• • Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
• • Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
• Exclusion Criteria:
• • Screening blood pressure \< 100/60 mmHg or \> 140/90 mmHg
• • Screening heart rate that is \< 40 bpm or \> 99 bpm
• • Clinically significant ECG abnormality at screening
• • Used prescription medication within 14 days prior to dosing
• • Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
• • Donated blood or had significant blood loss within 56 days prior to dosing