RecruitingPhase 1NCT07282171

A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months

An Open-Label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia Receiving Standard of Care, Expectant Management


Sponsor

Comanche Biopharma

Enrollment

60 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant Management. Eligible participants are between 26 +0/7 and 35 +6/7 weeks gestational age and clinically appropriate for inpatient expectant management. Eligible participants will receive standard of care expectant management for their pregnancy with the only study interventions being one subcutaneous dose of CBP-4888. Participants will: * receive a single subcutaneous injection dose of CBP-4888 and will be followed through delivery and for 42 days (+14 days) after delivery. Participants will be followed through 6 weeks post delivery. * Infants will be evaluated immediately postpartum and then followed through 24 months of age with standard infant and pediatric assessments with phone calls made to parents.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called CBP-4888 is safe for pregnant women hospitalized with preterm preeclampsia (dangerously high blood pressure during pregnancy) and for their children up to 2 years of age. **You may be eligible if...** - You are between 18 and 45 years old and are currently pregnant with a single baby - You have been hospitalized with preeclampsia (high blood pressure after 20 weeks of pregnancy, plus signs of organ problems) - You are between 26 and 35 weeks pregnant - Your condition is stable enough to remain hospitalized for at least 72 hours after receiving the study drug - You have signed consent to participate **You may NOT be eligible if...** - You are not expected to remain hospitalized until delivery - Your pregnancy is not considered stable by the medical team - You do not meet the health and safety requirements outlined by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBP-4888

Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.


Locations(2)

The Royal Women's Hospital

Parkville, Victoria, Australia

Royal Melbourne

Melbourne, Australia

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NCT07282171


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