Actively Recruiting
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
Led by Comanche Biopharma · Updated on 2026-05-08
60
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Provided written consent to participate
- Pregnant females aged 18 to 45 years
- Gestational age between 26 weeks 0 days and 35 weeks 6 days at Day 1
- Clinically stable and suitable for expectant management for at least 72 hours after CBP-4888 administration
- Carrying a singleton pregnancy
- Anticipated hospitalization through delivery
You will not qualify if you...
- Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding
- Fetal growth restriction below 3rd percentile or below 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 that may affect placental function
- Significant maternal medical conditions such as HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, lupus with nephritis or cerebritis
- Use of another investigational drug within 30 days prior to study entry
- Any other condition posing risk to mother or fetus as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Royal Women's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
2
Royal Melbourne
Melbourne, Australia
Actively Recruiting
Research Team
A
Aparna Shah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here