sFlt1 Mediated Preterm PreeclampsiaPhase 1NCT07282171
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
A Phase 1 study testing CBP-4888 in people with sFlt1 Mediated Preterm Preeclampsia and Preeclampsia, run by Comanche Biopharma at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- sFlt1 Mediated Preterm Preeclampsia, Preeclampsia, Preterm Preeclampsia
- What is being tested?
- CBP-4888
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesAustralia
- Study dates
- 26 Feb 2025to 31 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Monash University
Melbourne
Maddie Kendall, 0456 409 087, madeleine.kendall@monash.edu
- Recruiting
Royal Melbourne
Melbourne
Shaun Brennecke, Professor, (03) 8345 3703, shaun.brennecke@thewomens.org.au
- Recruiting
The Royal Women's Hospital
Parkville, Victoria, 3052
Shaun Brennecke, MD, s.brennecke@unimelb.edu.au
About this study
Official title: 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.
Read the 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.
- Being tested
- CBP-4888
- Keywords
- preterm preeclampsia, Hypertensive disorder of pregnancy, Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-4888Drug
Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.
| Study group | Role | What they receive |
|---|---|---|
| CBP-4888 | Experimental | On Day 1, participants will receive a subcutaneous dose of CBP-4888. Receives: Drug: CBP-4888 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks postpartum
Determine recommended phase 2 dose
To characterize the pharmacodynamic effect of CBP-4888 on maternal plasma sFlt1 levels
Measured: 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
To characterize the PK in plasma of CBP-4888
Measured: 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
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
Measured: From birth through 180 days of age
Time to Peak Concentration (Tmax) of siRNA-2283 siRNA-2519
To characterize PK in plasma of CBP-4888
Measured: 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
To Characterize PK in plasma of CBP-4888
Measured: 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
Neurodevelopment will be evaluated using the Ages and Stages Questionnaire, (ASQ-3), a validated parent-completed developmental screening tool.
Measured: From birth through 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start26 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for sFlt1 Mediated Preterm PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comanche Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282171
- Sponsor's protocol ID
- CBP-4888-101
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thadhani R, Karumanchi SA. Transforming Preeclampsia Care: Molecular Diagnostics and Therapeutic Innovations. J Am Soc Nephrol. 2026 Jul 8. doi: 10.1681/ASN.0000001197. Online ahead of print.
PubMed 42418275
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07282171
- Acronym / sponsor ID
- CBP-4888-101
- Keywords
- preterm preeclampsia, Hypertensive disorder of pregnancy, Preeclampsia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Comanche BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBP-4888 | Experimental | Drug: CBP-4888On Day 1, participants will receive a subcutaneous dose of CBP-4888. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-4888Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight. | Drug | CBP-4888 |
Primary outcome
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).
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
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42418275Thadhani R, Karumanchi SA. Transforming Preeclampsia Care: Molecular Diagnostics and Therapeutic Innovations. J Am Soc Nephrol. 2026 Jul 8. doi: 10.1681/ASN.0000001197. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP-4888 in people with sFlt1 Mediated Preterm Preeclampsia and Preeclampsia, run by Comanche Biopharma at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aparna Shah, MD (248-520-7361, ashah@comanchebiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07282171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.