What is the mechanism of action of this treatment?

The trial involving KBP-7072 and KBP-6079 focuses on understanding the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and safety profile of these compounds in healthy subjects. The mechanisms of action for such treatments typically involve targeting specific biological pathways or receptors to achieve desired therapeutic effects. For healthy subjects, understanding these mechanisms is crucial as it helps in determining the appropriate dosage, potential side effects, and overall safety of the drug before it is administered to patients with specific conditions. This foundational knowledge ensures that the drug can be used effectively and safely in broader clinical settings.

What side effects are associated with this type of intervention?

In clinical trials involving healthy subjects for pharmacokinetics and safety evaluations, common side effects include gastrointestinal disorders such as nausea, abdominal pain, and constipation. Other frequently reported adverse events are fatigue, dizziness, and mild respiratory issues like cough. These side effects are generally mild to moderate in intensity and are often manageable.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects typically involve early-phase clinical trials, such as Phase I studies, which focus on pharmacokinetics and safety. These trials often include single and multiple ascending dose studies to assess how the drug is absorbed, distributed, metabolized, and excreted, as well as to monitor for any adverse effects. Similar to the study of KBP-7072 and KBP-6079, these trials are crucial for determining the appropriate dosing and ensuring the safety of new drugs before they proceed to later phases involving patients with specific conditions.

What other types of research exist?

Promising novel alternatives to KBP-7072 and KBP-6079 for pharmacokinetics and safety evaluation in healthy subjects include the trastuzumab biosimilars MYL-1401O and PF-05280014. Both have demonstrated similar pharmacokinetic profiles and safety to EU-trastuzumab and US-trastuzumab in phase I trials, with no serious adverse events reported and good tolerability.

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KBP-7072 for Healthy Subjects

Phase 1

Waitlist Available

Led By Ronald Goldwater

Research Sponsored by KBP Biosciences

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 time frame: sad 1- 7 days and mad 1-17 days

Summary

This trial tests two new drugs, KBP-7072 and KBP-6079, in healthy volunteers. Researchers will measure how much of the drugs are in the blood and urine and check for any side effects to ensure they are safe. Kukoamine B (KB) has been studied for its behavior in human blood and urine.

Who is the study for?

This trial is for healthy men and women with a BMI between 18-30. Women must be nonchildbearing, either sterile or postmenopausal. Men must agree to use contraception. People can't join if they have significant health issues, abnormal eye exams recently, high blood pressure or cholesterol levels, drug/alcohol use, hepatitis/HIV positive status, recent Covid-19 vaccination, or fatty liver disease.

What is being tested?

The study tests KBP-7072 against a placebo in two parts: one where subjects get a single dose and another with multiple doses. Participants will stay at the facility for monitoring which includes blood/urine tests and safety checks like ECGs and physical exams.

What are the potential side effects?

Potential side effects are not specified but will be monitored through adverse event recording, lab evaluations including vital signs measurements, heart activity via ECGs and physical examinations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: sad 1- 7 days and mad 1-17 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: sad 1- 7 days and mad 1-17 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: sad 1- 7 days and mad 1-17 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

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

Secondary study objectives

Pharmacokinetics Parameters :AUC from time 0 extrapolated to infinity (AUC0-∞)

Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast)from time zero to time of last quantifiable concentration (AUC0-tlast)

Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KBP-7072Experimental Treatment1 Intervention

Proposed dose levels for Part A: 25, 50, 100, 150 and 200mg KBP-7072. Proposed dose levels for Part B: 50 and 100mg. Administration route is intravenous infusion.

Group II: PlaceboPlacebo Group1 Intervention

Placebo for intravenous infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KBP-7072

2015

Completed Phase 1

~150

Do I qualify?Apply below to find out

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

The trial involving KBP-7072 and KBP-6079 focuses on understanding the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and safety profile of these compounds in healthy subjects. The mechanisms of action for such treatments typically involve targeting specific biological pathways or receptors to achieve desired therapeutic effects. For healthy subjects, understanding these mechanisms is crucial as it helps in determining the appropriate dosage, potential side effects, and overall safety of the drug before it is administered to patients with specific conditions. This foundational knowledge ensures that the drug can be used effectively and safely in broader clinical settings.

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