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.
Hospitalized with a hypertensive disorder of pregnancy (preeclampsia) defined by elevated blood pressure after 20 weeks gestation with proteinuria or, in the absence of proteinuria, with evidence of organ dysfunction (e.g., thrombocytopenia, renal insufficiency, or impaired liver function), and expected to remain hospitalized through delivery
The subject has given written consent to participate in the study.
Pregnant participants aged 18 to 45 years of age
Gestational age at Day 1 between 26 weeks 0/7 days and 35 weeks 6/7 days
Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding.
Fetal growth restriction (<3rd percentile, or <10th percentile with abnormal Doppler) or known major chromosomal/genetic abnormalities.
Maternal conditions requiring immediate delivery (e.g., severe hypertension, eclampsia, non-reassuring fetal status, pulmonary edema).
Known active maternal infections considered to potentially affect placental function.
Single group
CBP-4888
DrugParticipants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.
Incidence of treatment emergent events and adverse events of special interest when CBP-4888 is administered to pregnant participants
Incidence of treatment-emergent adverse events (TEAEs) in pregnant participants receiving subcutaneous CBP-4888 through delivery (up to 6 weeks postpartum).
Determine recommended phase 2 dose
To characterize the pharmacodynamic effect of CBP-4888 on maternal plasma sFlt1 levels
Peak Plasma Concentration (Cmax) of siRNA-2283 siRNA-2519
To characterize the PK in plasma of CBP-4888
Incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) in Infants Exposed In Utero to CBP-4888
Infants born to participants who received CBP-4888 during pregnancy will be assessed for SAEs and AESIs to investigate long term safety of children of pregnant participants who were administered CBP-4888
Time to Peak Concentration (Tmax) of siRNA-2283 siRNA-2519
To characterize PK in plasma of CBP-4888
Area Under the Concentration (AUC)-Time Curve to Last Measurable Concentration of siRNA-2283 and siRNA-2519
To Characterize PK in plasma of CBP-4888
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