Actively Recruiting
Study of Single Ascending Doses of CBP-4888 to Evaluate Safety and Effects in Hospitalized Pregnant Women With Preterm Preeclampsia Receiving Standard Care
Led by Comanche Biopharma · Updated on 2026-05-18
60
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hospitalized women with preterm preeclampsia to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called CBP-4888. This open-label dose-finding study focuses on pregnant participants between 26 and nearly 36 weeks gestation who are receiving standard care with expectant management. The study aims to find the appropriate dose and monitor outcomes for both mothers and their babies. During the study, eligible participants will receive a single subcutaneous injection of CBP-4888 on Day 1, with dosing based on the participant's first trimester weight. Up to 60 participants will be enrolled across six dose levels, with all receiving standard care alongside the study drug. Mothers will be closely monitored through delivery and for six weeks postpartum, while their infants will be followed for up to 24 months with regular pediatric assessments. Participants will be observed for treatment-related events and adverse effects through six weeks after delivery. Infants will undergo evaluations immediately after birth and continue with developmental assessments using the Ages and Stages Questionnaire up to two years of age. The study tracks drug levels in the blood, safety signals, and long-term developmental outcomes to understand the effects of CBP-4888 on both mothers and their children.
CONDITIONS
Brief 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 evidence of organ dysfunction
- Written consent given to participate in the study
- Pregnant aged 18 to 45 years
- Gestational age between 26 weeks 0/7 days and 35 weeks 6/7 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 such as severe hypertension, eclampsia, non-reassuring fetal status, or pulmonary edema
- Active maternal infections potentially affecting placental function
- Significant maternal medical conditions including HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, or lupus with nephritis/cerebritis
- Use of another investigational drug within 30 days prior to study entry
- Any condition posing risk to mother or fetus as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 72 hours after dosing while hospitalized
Participants receive a single subcutaneous dose of CBP-4888 along with standard of care and expectant management while hospitalized.
1 dosing visit (in-person) plus safety surveillance visits through delivery and for 42 days postpartum
Duration - Up to 24 months postpartum
Mothers and their infants are monitored for safety and development after delivery. Infants are followed for neurodevelopmental outcomes up to 24 months of age.
Multiple follow-up visits for mother and infant continuing through 24 months for infants
Trial Site Locations
Total: 3 locations
1
The Royal Women's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
2
Monash University
Melbourne, Australia
Actively Recruiting
3
Royal Melbourne
Melbourne, Australia
Actively Recruiting
Research Team
A
Aparna Shah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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