NCT07282171RecruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 26 Feb 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Comanche Biopharma
- Diseases
- High blood pressure
- NCT number
- NCT07282171
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 26 Feb 2025 to the primary completion date, 31 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of another investigational drug within 30 days prior to study entry.
Other illness
- Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding.
- 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).
- Any other condition that, in the investigator's judgment, poses risk to mother or fetus.
Other
- Fetal growth restriction (\<3rd percentile, or \<10th percentile with abnormal Doppler) or known major chromosomal/genetic abnormalities.
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash University Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Royal Women's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.