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

15 Participants Needed

Trial Summary

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.

What safety data exists for CBP-4888 or similar treatments in humans?

The research does not provide specific safety data for CBP-4888 or similar treatments in humans. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new drug called CBP-4888 to see if it is safe and how it behaves in the body. It involves female participants who meet certain criteria. Different doses of the drug will be given to small groups to check for safety and tolerability.

Research Team

Allison August, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

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

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

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

A highly sensitive and selective method for the determination of Leukotriene B4 in human plasma by negative ion chemical ionization/gas chromatography/tandem mass spectrometry. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of anti-inflammatory and analgesic activity of a new class of biphenyl analogs in animal models of inflammation. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

CP-66,248, a new anti-inflammatory agent, is a potent inhibitor of leukotriene B4 and prostanoid synthesis in human polymorphonuclear leucocytes in vitro. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Profiling the Oxylipin and Endocannabinoid Metabolome by UPLC-ESI-MS/MS in Human Plasma to Monitor Postprandial Inflammation. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Study of sample preparation for determination of endocannabinoids and analogous compounds in human serum by LC-MS/MS in MRM mode. [2018]