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

May 15, 2026 updated by: Comanche Biopharma

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An Open-Label, 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. The study will follow a single ascending dose design, with up to 60 participants enrolled across 6 dose level groups. For each of the planned six dose levels, all 4 participants will receive a single SC injection dose of IP (CBP-4888) + standard of care (SOC)/Expectant Management + additional safety surveillance for the mother and neonate through delivery and for 42 days (+14 days) after delivery. Infants will be followed for up to 24 months.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBP-4888
On Day 1, participants will receive a subcutaneous dose of CBP-4888.
Drug: CBP-4888
Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent events and adverse events of special interest when CBP-4888 is administered to pregnant participants
Time Frame: 6 weeks postpartum
Incidence of treatment-emergent adverse events (TEAEs) in pregnant participants receiving subcutaneous CBP-4888 through delivery (up to 6 weeks postpartum).
6 weeks postpartum
Determine recommended phase 2 dose
Time Frame: From pre-dose on Day 1 through the last measurable concentration at approximately 72 hours postpartum in serum
To characterize the pharmacodynamic effect of CBP-4888 on maternal plasma sFlt1 levels
From pre-dose on Day 1 through the last measurable concentration at approximately 72 hours postpartum in serum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax) of siRNA-2283 siRNA-2519
Time Frame: From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
To characterize the PK in plasma of CBP-4888
From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
Incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) in Infants Exposed In Utero to CBP-4888
Time Frame: From birth through 180 days of age
Infants born to participants who received CBP-4888 during pregnancy will be assessed for SAEs and AESIs to investigate long term safety of children of pregnant participants who were administered CBP-4888
From birth through 180 days of age
Time to Peak Concentration (Tmax) of siRNA-2283 siRNA-2519
Time Frame: From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
To characterize PK in plasma of CBP-4888
From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
Area Under the Concentration (AUC)-Time Curve to Last Measurable Concentration of siRNA-2283 and siRNA-2519
Time Frame: From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
To Characterize PK in plasma of CBP-4888
From pre-dose on Day 1 through the last measurable concentration at approximately 120 hours post-dose
Neurodevelopmental Outcomes Assessed by the Ages and Stages Questionnaire (ASQ-3) to investigate long term safety of children of pregnant participants who were administered CBP-4888
Time Frame: From birth through 24 months of age
Neurodevelopment will be evaluated using the Ages and Stages Questionnaire, (ASQ-3), a validated parent-completed developmental screening tool.
From birth through 24 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comanche Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBP-4888-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia

Clinical Trials on CBP-4888

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe