Phase
Condition
Kidney Failure (Pediatric)
Renal Failure
Nephropathy
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 childbearing 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,implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptivepatches, IUD device or system or male partner sterilization
Men will not donate sperm during the study and for 1 month following the last doseof study drug.
Participants who are capable of directly providing informed consent and who cancomply with the requirements and restrictions required by the protocol
Adequate venous access sufficient to allow blood sampling per protocol requirements
Exclusion
Exclusion Criteria:
Participants positive for COVID-19 at the time of dosing
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 priorto the initial dose of study medication
Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
The participant has participated in a clinical trial and has received aninvestigational product within the following time ranges: prior to the first dosingday in the current study: either 30 days or 5 half-lives of the investigationalproduct (whichever duration is longer).
History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
History of severe allergic hypersensitivity reactions (unacceptable adverse events)or anaphylactoid 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 participanta poor candidate for participation in the clinical trial
Significant scaring, tattoos or alterations in pigmentation on the sternum or othersensor location testing areas that would alter sensor readings versus other areas ofthe skin
Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks ofdosing day
Use make-up, lotions, Vaseline or other products on the area of the upper chest onthe day prior to or the day of dosing
Any serious or uncontrolled medical disorder, active infection, physical examfinding, laboratory finding, or psychiatric condition that in the opinion of theinvestigator would limit the participant's ability to complete study requirements ormay put the participant at increased risk or compromise the interpretability ofstudy 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
Research by Design, LLC
Chicago, Illinois 60643
United StatesSite Not Available
Centricity Research
Columbus, Ohio 43213
United StatesSite Not Available
Centricity Research
Columbus,, Ohio 43213
United StatesSite Not Available
PPD
Austin, Texas 78744
United StatesSite Not Available
Clinical Advancement Center, PLLC
San Antonio, Texas 78212
United StatesSite Not Available
Endeavor Clinical Trials, LLC
San Antonio, Texas 78240
United StatesSite Not Available
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