Testing CBP-4888 in healthy women
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
This study is testing a new drug called CBP-4888 to see if it's safe and well-tolerated in healthy women.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Comanche Biopharma Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05881993 on ClinicalTrials.gov |
What this trial studies
This is a Phase I clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of CBP-4888 in healthy, non-pregnant female subjects. The study will be conducted in a single center and will utilize a randomized, double-blind, placebo-controlled design. Participants will receive a single subcutaneous dose of either CBP-4888 or a placebo, with doses administered in a sequential dose-escalation manner. The trial aims to ensure that all subjects meet specific health criteria and do not have any significant medical conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, non-pregnant women aged 18 to 45 with a BMI between 18.5 and 35.0 kg/m2.
Not a fit: Patients with significant health issues or those taking medications that could interfere with the study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could provide valuable safety and dosing information for future research on CBP-4888.
How similar studies have performed: Other studies involving similar early-phase assessments of new drugs have shown success in establishing safety and dosing parameters.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- Comanche Biopharma Clinical Research Site #1 — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jim Joffrion
- Email: jim@comanchebiopharma.com
- Phone: 800-876-8619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.