What is CBP-4888 studying for preterm preeclampsia?

CBP-4888 is being studied to evaluate its safety, how it is processed in the body, and its effects when given to hospitalized pregnant women with preterm preeclampsia. The study also monitors the health and development of their children up to 24 months of age. This research helps understand the drug's impact alongside standard care.

Who may be eligible for this preterm preeclampsia clinical trial?

Women aged 18 to 45 years who are pregnant with a single baby between 26 and 36 weeks gestation, diagnosed with preeclampsia, and hospitalized with plans to remain until delivery may be eligible. They must be clinically stable for expectant management and free from certain placenta or serious medical issues. Please review eligibility criteria for more details.

Is there any cost to participate in this preterm preeclampsia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses related to attending visits may vary and might not be covered. Participants can discuss any concerns about costs with the study team.

Actively Recruiting

Phase 1

Age: 18Years - 45Years

FEMALE

ID07282171

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

Participants Needed

Research Sites

104 weeks

Total Duration

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 participants 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

Age: 18Years - 45Years

FEMALE

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

Research Team

Aparna Shah, MD

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