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

NCT ID: NCT07282171

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-03-31

Brief Summary

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.

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.

Conditions

sFlt1 Mediated Preterm Preeclampsia; Preeclampsia; Preterm Preeclampsia

Keywords

preterm preeclampsia; Hypertensive disorder of pregnancy; Preeclampsia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBP-4888

On Day 1, participants will receive a subcutaneous dose of CBP-4888.

Group Type: EXPERIMENTAL

CBP-4888

Intervention Type: DRUG

Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.

Interventions

CBP-4888

Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Comanche Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Women's Hospital

Parkville, Victoria, Australia

Site Status: NOT_YET_RECRUITING

Royal Melbourne

Melbourne, , Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Aparna Shah, MD

Role: CONTACT

Phone: 248-520-7361

Email: ashah@comanchebiopharma.com

Facility Contacts

Shaun Brennecke, MD

Role: primary

Shaun Brennecke, Professor

Role: primary

Other Identifiers

CBP-4888-101

Identifier Type: -

Identifier Source: org_study_id