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

Sponsor
Comanche Biopharma
Study ID
NCT07282171
Phase
PHASE1
Status
Recruiting
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Conditions

  • Preeclampsia
  • Preterm Preeclampsia
  • sFlt1 Mediated Preterm Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 15, 2025
Start date
Feb 26, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of treatment emergent events and adverse events of special interest when CBP-4888 is administered to pregnant participants [ Time Frame: 6 weeks postpartum ]

Central Contacts

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