What is the mechanism of action of this treatment?

In Healthy Volunteer Studies, treatments like CBP-4888 are often evaluated for their safety, tolerability, and pharmacokinetics. These studies typically involve administering single ascending doses to understand how the drug interacts with the body, including its absorption, distribution, metabolism, and excretion. The mechanisms of action for these treatments usually involve targeting specific biological pathways or receptors to achieve therapeutic effects. This understanding is essential for ensuring the safety of volunteers, predicting potential side effects, and optimizing dosing regimens before the drug is tested in patients with the target condition.

What side effects are associated with this type of intervention?

In Phase I clinical trials like the CBP-4888 study, common side effects often include mild to moderate headaches, dizziness, nausea, fatigue, and localized reactions at the injection site such as pain, erythema, or bruising. Serious adverse effects are rare but can include allergic reactions or unexpected systemic effects. The primary goal of these trials is to identify any potential safety concerns before advancing to later stages of clinical development.

What prior FDA approvals exist?

Phase I trials, such as the one for CBP-4888, are designed to assess the safety, tolerability, and pharmacokinetics of new drugs in healthy volunteers. These trials are crucial for determining the appropriate dosage and identifying any potential side effects. While specific FDA approvals for drugs similar to CBP-4888 are not detailed in the provided context, it is common for new investigational drugs to undergo this rigorous testing phase before advancing to further clinical trials. The goal is to ensure that the drug is safe for use in humans and to gather preliminary data on its pharmacological properties.

What other types of research exist?

Seletalisib (UCB5857) is a promising alternative, as it demonstrated a high absolute oral bioavailability (97%), a favorable safety profile, and predictable pharmacokinetics in a phase 1 study. Additionally, PNB-028, a cholecystokinin A receptor antagonist, has shown a wide safety margin and potential efficacy in preclinical models, making it another viable candidate for further investigation in healthy volunteer studies.

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Unknown

CBP-4888 for Healthy Volunteers

Phase < 1

Recruiting

Research Sponsored by Comanche Biopharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an initial test of CBP-4888 in humans, potential side effects are not yet known but will be closely monitored for anything unusual like allergic reactions or symptoms affecting any part of the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Erythema at Site of Injection

Pain at Site of Injection

+2 more

Secondary study objectives

AUC of CBP-4888

Cmax of CBP-4888

Tmax of CBP-4888

Other study objectives

Pharmacodynamics

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CBP-4888Experimental Treatment1 Intervention

CBP-4888 administered once as a subcutaneous dose.

Group II: PlaceboPlacebo Group1 Intervention

Normal Saline administered once as a subcutaneous dose.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In Healthy Volunteer Studies, treatments like CBP-4888 are often evaluated for their safety, tolerability, and pharmacokinetics. These studies typically involve administering single ascending doses to understand how the drug interacts with the body, including its absorption, distribution, metabolism, and excretion. The mechanisms of action for these treatments usually involve targeting specific biological pathways or receptors to achieve therapeutic effects. This understanding is essential for ensuring the safety of volunteers, predicting potential side effects, and optimizing dosing regimens before the drug is tested in patients with the target condition.

Improving participant adherence in clinical research of traditional chinese medicine.