CBP-4888 for hospitalized people with preterm preeclampsia
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
This study tests whether a single injection of CBP-4888 is safe and how it behaves in the body for hospitalized pregnant people with preterm preeclampsia, and follows their babies for up to 24 months.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Comanche Biopharma Industry-sponsored |
| Locations | 2 sites (Parkville, Victoria and 1 other locations) |
| Trial ID | NCT07282171 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-ascending-dose Phase 1 study enrolling up to 60 hospitalized participants with preterm preeclampsia between 26+0/7 and 35+6/7 weeks gestation. Each participant will receive one subcutaneous dose of CBP-4888 alongside standard expectant management, with cohorts of four participants per dose level across six planned dose levels. The study will collect safety, tolerability, pharmacokinetic, and pharmacodynamic data through delivery and for six weeks postpartum for the mother. Infants will be evaluated at birth and followed with standard pediatric assessments and phone follow-up through 24 months of age.
Who should consider this trial
Good fit: Hospitalized pregnant people aged 18–45 with a singleton pregnancy diagnosed with preterm preeclampsia at 26+0/7 to 35+6/7 weeks who are clinically appropriate for at least 72 hours of inpatient expectant management are candidates.
Not a fit: People requiring immediate delivery, those with placenta previa/abruption/accreta or unexplained bleeding, major fetal anomalies, severe fetal growth restriction, multifetal pregnancies, or outside the specified gestational window are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, CBP-4888 could offer a targeted treatment option that helps manage preterm preeclampsia and potentially prolong pregnancy to improve outcomes for newborns.
How similar studies have performed: This is an early-phase, first-in-pregnancy dose-finding effort for CBP-4888; while other experimental approaches targeting sFlt1 pathways have been explored in early research, clinical evidence for this specific agent is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Deemed clinically stable and suitable for expectant management for at least 72 hours post CBP-4888 administration * The woman carries a singleton pregnancy * Anticipate that hospitalization will continue through delivery Exclusion Criteria: * 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. * Significant maternal medical conditions (e.g., HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, lupus with nephritis/cerebritis). * Use of another investigational drug within 30 days prior to study entry. * Any other condition that, in the investigator's judgment, poses risk to mother or fetus.
Where this trial is running
Parkville, Victoria and 1 other locations
- The Royal Women's Hospital — Parkville, Victoria, Australia (Recruiting)
- Royal Melbourne — Melbourne, Australia (Recruiting)
Study contacts
- Study coordinator: Aparna Shah, MD
- Email: ashah@comanchebiopharma.com
- Phone: 248-520-7361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.