Phase
Condition
Renal Failure
Nephropathy
Kidney Disease
Treatment
MB-102
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Eligible female non-pregnant participants who are either not of child-bearingpotential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception fromdosing day to at least 7 days post-dose
- For women of child-bearing potential, the participant should have a negative serumpregnancy test at screening, and agrees to one of the following acceptablecontraceptive methods used consistently and correctly i.e. abstinence, oralcontraceptive either combined or progesterone alone; injectable progesterone, implantsof levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUDdevice or system or male partner sterilization
- Men will not donate sperm during the study and for 1 month following the last dose ofstudy drug
- Participants who are capable of directly providing informed consent and who can complywith the requirements and restrictions required by the protocol
- Adequate venous access sufficient to allow blood sampling per protocol requirements
Exclusion
Exclusion Criteria:
- Participants positive via PCR testing for COVID-19 (Vaccinated participants withoutsymptoms of COVID-19 are not required to undergo PCR testing but may be tested at thediscretion of the study site)
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior tothe initial dose of the study medication; or more than 499 mL within 56 days prior tothe initial dose of study medication
- Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
- Participant has participated in a clinical trial and has received an investigationalproduct within the following time ranges: prior to the first dosing day in the currentstudy: either 30 days or 5 half-lives of the investigational product (whicheverduration is longer)
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) oranaphylactoid reaction to any allergen including drugs, MB-102 or other relatedproducts (intolerance to a drug is not considered a drug allergy).
- Any characteristics which, in the opinion of the investigator, makes the participant apoor candidate for participation in the clinical trial
- Significant scarring, tattoos or alterations in pigmentation on the sternum or othersensor location testing areas that would alter sensor readings versus other areas ofthe skin
- Any serious or uncontrolled medical disorder, active infection, physical exam finding,laboratory finding, or psychiatric condition that in the opinion of the investigatorwould limit the participant's ability to complete study requirements or may put theparticipant at increased risk or compromise the interpretability of study results.
- Currently receiving dialysis
- Currently anuric
- Positive serum pregnancy test
- Participants with an eGFR > 120 mL/min/1.73m^2
Study Design
Connect with a study center
West China Hospital of Sichuan University
Chengdu, Sichuan 610093
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
ChinaSite Not Available
Affiliated Hospital of Xuzhou Medical University
Xuzhou, 2210029
ChinaSite Not Available
Velocity Clinical Research
Edgewater, Florida 32132
United StatesSite Not Available
Research by Design, LLC
Chicago, Illinois 60643
United StatesSite Not Available
Nucleus Network
Saint Paul, Minnesota 55114
United StatesSite Not Available
Carolina Phase I Research
Raleigh, North Carolina 27612
United StatesSite Not Available
Endeavor Clinical Trials, LLC
San Antonio, Texas 78240
United StatesSite Not Available
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