A study to investigate the safety, pharmacodynamic and pharmacokinetic characteristics of CBP-4888 in hospitalized participants with preterm preeclampsia and the safety and tolerability of CBP-4888 on their children.
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
Comanche Biopharma (AU) Pty Ltd
60 participants
Dec 5, 2025
Interventional
Conditions
Summary
This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous CBP-4888-101 in hospitalised 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 intervention being one subcutaneous dose of CBP-4888.
Eligibility
Inclusion Criteria20
- Participant understands study procedures and provides written informed consent, which includes compliance with the protocol and assessments herein.
- Pregnant participants aged 18 to 45 years of age (inclusive) at the time of consent.
- Gestational age at Day 1 (IMP Administration Day) between 26 weeks 0/7 days and 35 weeks 6/7 days. Gestational age dating criteria is based on the earliest ultrasound provided it has been performed prior to the 22 1/7 weeks gestation.
- Singleton gestation.
- sFlt1/PlGF ratio greater than 38 and equal to 655 and an absolute sFlt-1 value of greater than 5000 pg/mL prior to CBP-4888 administration.
- Deemed clinically stable and suitable for expectant management for at least 72 hours post-IMP administration in the opinion of the Investigator and per institutional standards.
- Anatomic survey ultrasound (anomaly scan) at 18 to 23 weeks’ gestation showing an absence of major congenital anomalies.
- Hospitalized with (or developed while hospitalized) a hypertensive disorder of pregnancy as defined below (modified American College of Obstetricians and Gynecologists diagnostic criteria for preeclampsia).
- a. Blood pressure
- i. Systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more on two occasions at least 4 hours apart after 20 weeks of gestation in a participant with a previously normal blood pressure or
- ii. Systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 110 mmHg or more. (Severe hypertension can be confirmed within a short interval (minutes) to facilitate timely antihypertensive therapy).
- AND
- b. Proteinuria
- i. 300 mg or more per 24-hour urine collection (or this amount extrapolated from a time collection) OR
- ii. Protein/creatinine ratio of 0.3 or more OR
- iii. Dipstick reading of 2+ (used only if other quantitative methods are not available).
- c. OR, in the absence of proteinuria, hypertension with the new onset of any of the following:
- i. Thrombocytopenia (TCP): Platelet count 1.1 mg/dL (and equals 1.4 mg/dl) or, if less than 1.1 mg/dL, a doubling of the serum creatinine concentration from the first prenatal visit or first creatinine level obtained during current pregnancy in the absence of other renal disease.
- iii. Impaired liver function: blood concentrations of liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST], or both) greater than two times the upper limit of normal concentration.
- Anticipate that hospitalization will continue through delivery.
Exclusion Criteria14
- Multifetal gestation (patients with a history of vanishing twin syndrome may be enrolled).
- Absence of ultrasound with dating information, prior to 22 0/7 weeks GA.
- Placenta previa, abruption or persistent vaginal bleeding unrelated to cervical exam, placenta accreta, percreta or increta.
- Fetus with known chromosomal abnormality and/or major fetal malformations.
- Any known fetal condition likely to cause death or require prolonged hospitalization in the first year of life.
- Participant requires, or potentially may require, immediate delivery of the fetus including, but not limited to, known presence of any of the following prior to CBP-4888 administration.
- a. Non-reassuring fetal heart rate tracing
- b. Abnormal umbilical artery doppler (reverse or absent flow)
- c. Persistent oligohydramnios
- d. Eclampsia
- e. Participants with persistent headaches that are refractory to treatment and directly related to disease progression in the opinion of the Principal Investigator
- f. New onset of persistent visual disturbances
- g. Pulmonary edema
- Any other condition the Investigator deems an exclusionary risk to the participant or the fetus, such as preterm pre-labor rupture of membranes (PPROM), antiphospholipid antibody syndrome, atypical hemolytic uremic syndrome, or paroxysmal nocturnal hemoglobinuria.
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Interventions
Participants will receive a single dose of CBP-4888-101 via subcutaneous injection. There are 6 planned dose levels: * 0.5mg/kg * 1.0 mg/kg * 2.0 mg/kg * 3.0 mg/kg * 4.0 mg/kg * 5.0 mg/kg The injection(s) will be administered by a registered nurse or medical doctor and documented in the participant's medical record. The pregnant participant will be hospitalised for dosing and will be followed in the hospital post-dose through delivery. She will be discharged postnatally per standard of care. The pregnant participant will be followed further until 42 days postpartum, while the infant will be followed through 24 months. A Safety Monitoring Committee will review maternal, fetal, and neonatal safety data through 72 hours postpartum and make recommendations regarding subsequent dosing. Adherence will be monitored via review of source documentation, including electronic medical records and site-maintained source documents. Completion and timing of each intervention administration will be recorded in the study Case Report Forms.
Locations(1)
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ACTRN12625001324404