Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MediBeacon

Criteria

Inclusion Criteria:

• Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial

• Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose

• For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization

• Men will not donate sperm during the study and for 1 month following the last dose of study drug

• Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol

• Adequate venous access sufficient to allow blood sampling per protocol requirements

Exclusion Criteria:

• Participants positive via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)

• Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the 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 investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (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 related products (intolerance to a drug is not considered a drug allergy).

• Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial

• Significant scaring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin

• Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the participant 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