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

NCT07282171 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CBP-4888-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

sFlt1 Mediated Preterm Preeclampsia; Preeclampsia; Preterm Preeclampsia

Keywords

preterm preeclampsia; Hypertensive disorder of pregnancy; Preeclampsia

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent events and adverse events of special interest when CBP-4888 is administered to pregnant participants

  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

  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 Outcomes (5)

• Peak Plasma Concentration (Cmax) of siRNA-2283 siRNA-2519

  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

  From birth through 180 days of age

• Time to Peak Concentration (Tmax) of siRNA-2283 siRNA-2519

  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

  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

  From birth through 24 months of age

Study Arms (1)

CBP-4888

EXPERIMENTAL

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

Drug: CBP-4888

Interventions

CBP-4888 DRUG

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

CBP-4888

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comanche Biopharma: lead

Study Sites (2)

The Royal Women's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

Royal Melbourne

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Toxemia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections

Central Study Contacts

Aparna Shah, MD

CONTACT

248-520-7361; ashah@comanchebiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will follow a single ascending dose design, with up to 60 participants enrolled across 6 dose levels. For each of the planned dose levels, all 4 participants will receive a subcutaneous dose of IP (CBP-4888) + standard of care (SOC)/Expectant Management + additional safety surveillance.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 15, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

AU (2)