CBP-4888 for Healthy Volunteers

Overseen By Jim Joffrion

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Comanche Biopharma

Must not be taking: Prescription, OTC medications

Disqualifiers: Hypertension, Bradycardia, Tachycardia, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called CBP-4888. Healthy volunteers will be randomly assigned to receive either the treatment or a placebo (a harmless substance). As an early phase trial, the focus is on determining if CBP-4888 is safe and how the body processes it. The trial seeks healthy women with no major health issues who are not on any medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescription medications 14 days before the trial and over-the-counter medications 7 days before the trial.

Is there any evidence suggesting that CBP-4888 is likely to be safe for humans?

Research shows that CBP-4888 remains in the early testing stages, so limited information exists about its safety in humans. Researchers are testing the treatment in a controlled setting with healthy volunteers to assess its safety and tolerability.

This marks the first time CBP-4888 undergoes testing in humans. In this early phase, the primary goal is to determine its safety and how it functions in the body. Although safety information from early trials is often limited, it is crucial for understanding potential reactions to the drug.

With no previous human data, participants should understand that this trial primarily focuses on assessing the treatment's safety. As the trial progresses and more participants are studied, more detailed safety information will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CBP-4888 is unique because it introduces a new approach by being administered as a single subcutaneous dose, which could offer a more convenient option compared to existing treatments that might require more frequent dosing or different methods of administration. Researchers are particularly excited about the potential for CBP-4888 to deliver its effects quickly and efficiently through this innovative delivery method. This could lead to improved patient compliance and overall outcomes, setting it apart from the standard treatments currently available.

What evidence suggests that CBP-4888 could be effective?

Research has shown that CBP-4888, which participants in this trial may receive, uses two small molecules called siRNAs to target specific disease-linked genes. These siRNAs stop the production of proteins that may cause illness. Early results suggest this method can effectively disrupt disease processes at a fundamental level. The FDA has granted the treatment fast-track status, indicating it shows enough promise to expedite its development and review. Although human study data is limited, this approach has the potential to significantly help manage conditions related to these genetic targets. ^{1 3 6 7 8}

Who Is on the Research Team?

Allison August, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

This trial is for healthy, non-pregnant women with a BMI between 18.5 and 35.0 kg/m2. Participants should have no significant health issues based on lab tests, medical history, vital signs, ECGs, or physical exams as determined by the study's doctor.

Inclusion Criteria

Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.

I am a healthy woman and not pregnant.

Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2

Exclusion Criteria

I have used over-the-counter meds or supplements in the last week.

I have taken prescription medication within the last 14 days.

Screening blood pressure < 100/60 mmHg or > 140/90 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of CBP-4888 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• CBP-4888
• Placebo

Trial Overview The study is testing CBP-4888 in its first human trial phase to see how safe it is and how the body processes it. It's a randomized test where some get CBP-4888 and others get a placebo without knowing which one they receive.

How Is the Trial Designed?

Group I: CBP-4888 Experimental Treatment 1 Intervention

CBP-4888 administered once as a subcutaneous dose.

Group II: Placebo Placebo Group 1 Intervention

Normal Saline administered once as a subcutaneous dose.

Who Is Running the Clinical Trial?

Comanche Biopharma

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05881993

Study of CBP-4888 in Healthy, Non-Pregnant Female ... A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10418829/

New Ideas for the Prevention and Treatment of Preeclampsia ... The safety, tolerability, and pharmacokinetics of the single ascending dose of CBP-4888 will be evaluated in healthy, nonpregnant women in a clinical randomised ...

3. dmd.aspetjournals.org dmd.aspetjournals.org/article/S0090-9556(24)14861-1/fulltext

The absorption, distribution, metabolism and elimination ... Recently, the FDA granted fast-track designation to CBP-4888, a fixed-dose combination of 2 lipid-conjugated siRNAs (siRNA-2283 and siRNA-2519) targeting ...

4. prnewswire.com prnewswire.com/news-releases/comanche-biopharma-drug-receives-fda-fast-track-designation-301908285.html

Comanche Biopharma Receives US FDA Fast Track ... "This designation offers increased collaboration with the FDA to help ensure that CBP-4888 reaches patients expeditiously while maintaining the ...

5. trial.medpath.com trial.medpath.com/clinical-trial/e09d18b213691442/nct05881993-safety-tolerability-pharmacokinetics-cbp-4888

Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability ...

6. withpower.com withpower.com/trial/early-phase-1-healthy-volunteer-study-4-2023-68906

CBP-4888 for Healthy Volunteers · Info for Participants The CBP-4888 trial tests the drug's safety and behavior in healthy, non-pregnant women (BMI 18.5-35.0) with no significant health issues. It is a randomized ...

7. synapse.patsnap.com synapse.patsnap.com/drug/e8ee4298b1994f33bd454069e304837e

CBP-4888 - Drug Targets, Indications, Patents Comanche completed a randomised placebo-controlled Phase I trial (NCT05881993) of CBP-4888 in healthy non-pregnant volunteers. The study enrolled approximately ...

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/comanche-raises-75m-to-develop-preeclampsia-therapy-2/

Comanche raises $75m to develop preeclampsia therapy Comanche completed a randomised placebo-controlled Phase I trial (NCT05881993) of CBP-4888 in healthy non-pregnant volunteers. The study ...