Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-12-01; most recent amendment 2026-05-15.
Status change: Not Yet Recruiting → Recruiting 2025-12-18
Trial Details
NCT Number NCT07282171
Lead Sponsor Comanche Biopharma
Conditions sFlt1 Mediated Preterm Preeclampsia, Preeclampsia, Preterm Preeclampsia
Enrollment 60 participants
Start Date 2025-02-26
Primary Completion 2027-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-18