← Back to Search

Other

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
Awards & highlights

Study Summary

This trial is testing a new drug, KBP-7072, to see if it is safe and effective. The trial has two parts. In the first part, single doses of the drug are given to a small group of people to see how it affects them. In the second part, multiple doses of the drug are given to another small group of people. Safety is monitored throughout the trial by recording any adverse events, checking laboratory results, and taking physical measurements.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Secondary outcome measures
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

Find a Location

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
303 Previous Clinical Trials
100,770 Total Patients Enrolled
Ronald GoldwaterPrincipal InvestigatorParexel
2 Previous Clinical Trials
46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population taking part in this experiment?

"Affirmative. Resources available on clinicaltrials.gov confirm that this medical research initiative, which was initially announced on August 16th 2022, is currently recruiting participants. Exactly 56 patients need to be enlisted from a single location."

Answered by AI

Is there an opportunity for me to take part in this clinical experiment?

"This trial seeks 56 healthy participants aged 18 to 50 years old with a Body Mass Index falling between 18 and 30 kg/m2. Additionally, candidates must have no outstanding medical issues as per the results of their physical exam, 12-lead ECG, vital sign readings, and clinical lab tests. Females not intending on bearing children are also eligible for this study while males need to commit to using contraception methods."

Answered by AI

Are individuals of a youthful age being accepted for this medical experiment?

"Eligibility for the trial is restricted to those aged 18-50; younger and older patients may find studies that meet their needs with 50 trials targeting under 18s or 372 studies addressing participants over 65."

Answered by AI

Are there any enrollment openings in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this clinical trial is actively recruiting participants, initially posted on August 16th, 2022 and updated as recently as the same date. There are 56 openings at one location for those interested in enrolling."

Answered by AI

What detrimental effects has KBP-7072 been associated with in humans?

"There is limited evidence in regards to KBP-7072's efficacy and safety, thus it earned a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of KBP-7072 in Healthy Male and Female Subjects
2022. "Study of KBP-7072 in Healthy Male and Female Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507463.
~21 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top