CBP-4888 for hospitalized people with preterm preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Royal Women's Hospital
  Parkville, Victoria, Australia Recruiting
• Monash University
  Melbourne, Australia Recruiting
• Royal Melbourne
  Melbourne, Australia Recruiting

Study contacts

• Study coordinator: Aparna Shah, MD
• Email: ashah@comanchebiopharma.com
• Phone: 248-520-7361

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Role of Progesterone Membrane Receptors in Preeclampsia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.