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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
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 moreTrial 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
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
KBP BiosciencesLead Sponsor
12 Previous Clinical Trials
1,046 Total Patients Enrolled
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,393 Total Patients Enrolled
Ronald GoldwaterPrincipal InvestigatorParexel
2 Previous Clinical Trials
46 Total Patients Enrolled
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