Study of Safety and Effects of Single Dose CBP-4888 Injection in Hospitalized Pregnant Women with Preterm Preeclampsia and Follow-Up of Their Children up to 24 Months

What this Trial Is About

Researchers are studying hospitalized women with preterm preeclampsia to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called CBP-4888. This open-label dose-finding study focuses on pregnant participants between 26 and nearly 36 weeks gestation who are receiving standard care with expectant management. The study aims to find the appropriate dose and monitor outcomes for both mothers and their babies. During the study, eligible participants will receive a single subcutaneous injection of CBP-4888 on Day 1, with dosing based on the participants first trimester weight. Up to 60 participants will be enrolled across six dose levels, with all receiving standard care alongside the study drug. Mothers will be closely monitored through delivery and for six weeks postpartum, while their infants will be followed for up to 24 months with regular pediatric assessments. Participants will be observed for treatment-related events and adverse effects through six weeks after delivery. Infants will undergo evaluations immediately after birth and continue with developmental assessments using the Ages and Stages Questionnaire up to two years of age. The study tracks drug levels in the blood, safety signals, and long-term developmental outcomes to understand the effects of CBP-4888 on both mothers and their children.

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