New injection aims to tame dangerous pregnancy condition

NCT ID NCT07282171

Disease control Sponsor: Comanche Biopharma Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a single injection of CBP-4888 in 60 pregnant women hospitalized with preterm preeclampsia, a serious condition involving high blood pressure and organ stress. The goal is to find a safe dose and see if the drug can lower a harmful protein called sFlt1. Participants receive standard care plus the study drug, and both mothers and babies are followed for months after delivery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CBP-4888 (a drug given as a single injection under the skin)
What this could lead to: If it works, this could lead to a new treatment that helps manage preterm preeclampsia by lowering a harmful protein in the blood, potentially allowing safer continuation of pregnancy.
What could go wrong: This is an early Phase 1 trial with only 60 participants, so safety and effectiveness are not yet proven. The drug may not lower the protein enough or could cause unexpected side effects in mothers or babies.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

preeclampsia Toxemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia Preterm preeclampsia SFLT1 mediated preterm preeclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New injection aims to tame dangerous pregnancy condition

What the study statuses mean