Pharmacokinetics of MB-102 and Use of the Non-invasive Op... | NCT02772276

Label	Type	Description	Intervention Names
Normal-CKD Stage 2/QuantumLeap	Experimental	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.	Drug: MB-102-- single dose of 4 µmol/kg Drug: Iohexol Device: QuantumLeap
CKD Stage 3-4/QuantumLeap	Experimental	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.	Drug: MB-102-- single dose of 4 µmol/kg Drug: Iohexol Device: QuantumLeap
Normal-CKD Stage 2/Radiance	Experimental	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	Drug: MB-102-- single dose of 4 µmol/kg Drug: Iohexol Device: Radiance
CKD Stage 3-5/Radiance

Name	Type	Description	Arm Group Labels	Other Names
MB-102-- single dose of 4 µmol/kg	Drug	4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.	From the time of dosing through the follow-up visit, up to 10 days

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of MB-102	Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.	Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

Main Criteria for Inclusion (Quantum Leap and Radiance device)

Age > 22 years - male or female
- Eligible female non-pregnant participants who are either not of childbearing 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
Participants willing to comply with study requirements
Participants who have signed an informed consent form
Normal or non-clinically significant screening and baseline 12-lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
Adequate venous access sufficient to allow blood sampling per protocol requirements

Main Criteria for Inclusion (Brilliance device)

Age > 18 years - male or female
- Eligible female non-pregnant participants who are either not of childbearing 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
Participants willing to comply with study requirements
Participants who have signed an informed consent form
Normal or non-clinically significant screening and baseline 12-lead ECG in the opinion of the PI
Adequate venous access sufficient to allow blood sampling per protocol requirements

Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor optimization; and Normal-CKD Stage 2/Brilliance (1-2 sensors)

Are healthy as determined by medical history, with no clinically significant findings on screening and baseline physical exams, vital signs and clinical laboratory panels or conditions that could adversely impact the participant's participation or safety, conduct of the study or interfere with study assessments
Have estimated glomerular filtration rate (eGFR (Chronic kidney disease - epidemiology collaboration [CKD-EPI] equation) of ≥60 ml/min/1.73m^2 (normal to Stage 2 CKD) at the time of screening
Approximately half of the participants enrolled in each cohort to have Fitzpatrick Scale Type I, II or III skin color type
Approximately half of the participants enrolled in each cohort to have Fitzpatrick Type IV, V or VI skin color type.

CKD Stage 3-4/QuantumLeap

Possess stable renal function in the opinion of the PI
Have eGFR (CKD-EPI equation) of 15 - 59 mL/min/1.73m^2 at the time of screening
Stable use of immunosuppressant medications (when applicable)
- 15 participants per cohort to have Fitzpatrick Type I, II or III skin color type
- 15 participants per cohort to have Fitzpatrick Type IV, V or VI skin color type

CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors

Possess stable renal function as defined as the most recent historical (within 3 months) eGFR and screening eGFR differing by ≤20%.
Have eGFR (CKD-EPI equation) of <59 mL/min/1.73m^2 based on a historical value collected within 3 months or from the screening serum creatinine
Stable use of immunosuppressant medications (when applicable) defined as no changes in the last 30 days or expected through the follow up visits, and a prednisone dose of <20 mg/day (or another steroid's equivalent dose)
Approximately half of the participants in each cohort to have Fitzpatrick Type I, II or III skin color type
Approximately half of the participants in each cohort to have Fitzpatrick Type IV, V or VI skin color type

EXCLUSION CRITERIA

Main Criteria for Exclusion (QuantumLeap device)

Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
Intolerant to venipuncture
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
Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
History of drug or alcohol abuse within the past year
History of allergy or hypersensitivity to MB-102 or iohexol, or other related (iodinated contrast media) products, or any of the inactive ingredients
History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
Any food allergy, intolerance, restriction or special diet that, in the opinion of the PI, could contraindicate the subject's participation in this study
Participants who have allergies to 2 or more classes of drugs. (Intolerance to a drug is not considered a drug allergy)
Stable use (no changes within 30 days) of prescription or over the counter (OTC) medications
Non-steroidal anti-inflammatory drug (NSAID) use within 2 days of dosing day
History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
Are homozygous for sickle cell disease
Have a known thyroid disorder
Have pheochromocytoma
Currently on Coumadin (warfarin) who have an International normalized ratio (INR) >4 at Screening
Current history of AIDS or HIV
Hepatitis B antigen positive, or C antibody positive
Site personnel immediately associated with the study or their immediate family members
Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
Prior enrollment and dosing in this Pilot 2 study
Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin

Additional Exclusion: Normal-CKD Stage 2/QuantumLeap

• History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, pulmonary, hematologic, endocrine, hepatobiliary, nephrologic, immunologic, dermatologic, neurologic (including any history of stroke and/or seizure disorder), psychological, musculoskeletal disease, diagnosis of cancer with the past 2 years or deemed clinically significant or unstable by the Principal Investigator; Note: history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.

Additional Exclusion: CKD Stage 3-4/QuantumLeap

Stage 5 CKD at the time of screening
Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, laparoscopic procedures, or other medical inventions
Doses of prednisone greater than 10 mg/day within the last 90 days

Main Criteria for Exclusion: (Radiance device)

Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control

o Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
Unable to have venous access placed in both arms
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
Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
History of drug or alcohol abuse within the past year
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 and iohexol or other related (iodinated contrast media) products (intolerance to a drug is not considered a drug allergy)
NSAID use within 2 days of dosing day
History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
Are homozygous for sickle cell disease
Have hyperthyroidism or current thyroid cancer
Have pheochromocytoma
Currently on Coumadin (warfarin) who have an INR >4 at Screening
Current history of AIDS or HIV
Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
Site personnel immediately associated with the study or their immediate family members
Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for participation in the clinical trial
Prior exposure to MB-102
Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin

Main Criteria for Exclusion: (Brilliance device)

Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control

o Males must be unwilling to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
Unable to have venous access
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
Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
History of drug or alcohol abuse within the past year
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, or MB-102 (intolerance to a drug is not considered a drug allergy)
NSAID use within 2 days of dosing day
History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
Currently on Coumadin (warfarin) who have an INR >4 at Screening
Current history of AIDS or HIV
Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
Site personnel immediately associated with the study or their immediate family members
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 that would alter sensor readings versus other areas of the skin

Additional Exclusion: Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD Stage 2/Brilliance (1-2 sensors)

History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, or NYHA class III or IV HF
Any other 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 subject at increased risk or compromise interpretability of study results. Note: a history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.

Additional Exclusion: CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors

Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, thoracic laparoscopic procedures, or other significant medical inventions
Received >20 mg/day of prednisone or an equivalent dose of glucocorticoid for more than 7 days in the last 90 days prior to dosing day for an acute or chronic disorder
Currently receiving dialysis
Currently anuric

Name	Affiliation	Role
Richard B Dorshow, PhD	MediBeacon, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Riverside Clinical Research		Edgewater	Florida	32132	United States
Orlando Clinical Research Center

PubMed Identifier	Type	Citation	Retractions
39918882	Derived	Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.

ID	Title	Description
FG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 18, 2021

Arm/Group Information

ID	Title	Description
BG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
BG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
BG002	Normal-CKD Stage 2/Radiance	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG003	CKD Stage 3-5/Radiance	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG004	Normal-CKD Stage 2/Brilliance Algorithm Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG005	CKD Stage 3-5/Brilliance Algorithm Optimization	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG006	Normal-CKD Stage 2/Brilliance Sensor Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG007	Normal-CKD Stage 2/Brilliance Sensor Validation	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG008	CKD Stage 3-5/Brilliance Sensor Validation	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG009	Normal-CKD Stage 2/Brilliance (1-2 Sensors)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.
BG010	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.
BG011	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG012	CKD Stage 3-5/Brilliance 1-2 Sensors	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
BG013	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-Emergent Adverse Events

An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Posted

Count of Participants

Participants

From the time of dosing through the follow-up visit, up to 10 days

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG002	Normal-CKD Stage 2/Radiance	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG003	CKD Stage 3-5/Radiance	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG004	Normal-CKD Stage 2/Brilliance Algorithm Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG005	CKD Stage 3-5/Brilliance Algorithm Optimization	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG006	Normal-CKD Stage 2/Brilliance Sensor Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG007	Normal-CKD Stage 2/Brilliance Sensor Validation	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG008	CKD Stage 3-5/Brilliance Sensor Validation	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG009	Normal-CKD Stage 2/Brilliance (1-2 Sensors)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.
OG010	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function,and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.
OG011	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG012	CKD Stage 3-5/Brilliance 1-2 Sensors	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Units	Counts
Participants	OG00031 OG00129 OG00220 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007 OG0017 OG0022 OG003

Secondary

Maximum Plasma Concentration (Cmax) of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Maximum Plasma Concentration (Cmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Time to Maximum Plasma Concentration (Tmax) of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Time to Maximum Plasma Concentration (Tmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

The Elimination Half-life of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

The Elimination Half-life of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

ng*min/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

ng*min/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

ng*min/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

ng*min/mL

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Total Plasma Clearance of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

mL/minute

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Total Plasma Clearance of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

mL/minute

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

The Terminal Rate Constant for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

1/minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

The Terminal Rate Constant for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

1/minutes

Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Renal Clearance of MB-102

Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

All participants who received study drug and had no major protocol deviations.

Posted

Mean

Standard Deviation

mL/minute

Pre-dose and each time the participant voids up to 720 minutes post dose

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Renal Clearance of Iohexol

All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Posted

Mean

Standard Deviation

mL/minute

Pre-dose and each time the participant voids up to 720 minutes post dose

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

All participants who received study drug and had no major protocol deviations

Posted

Mean

Standard Deviation

Coefficient of determination, r-squared

Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

All participants who received study drug and had no major protocol deviations

Posted

Mean

Standard Deviation

Coefficient of determination, r-squared

Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose

ID	Title	Description
OG000	Normal-CKD Stage 2/Radiance	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG001	CKD Stage 3-5/Radiance	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

All participants who received study drug and had no major protocol deviations

Posted

Mean

Standard Deviation

Coefficient of determination, r-squared

Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose

ID	Title	Description
OG000	Normal-CKD Stage 2/Brilliance Algorithm Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG001	Normal-CKD Stage 2/Brilliance Sensor Optimization

Secondary

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

All participants who received study drug and had no major protocol deviations

Posted

Mean

Standard Deviation

Coefficient of determination, r-squared

Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose

ID	Title	Description
OG000	CKD Stage 3-5/Brilliance Algorithm Optimization	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Secondary

Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device

The number of participants with adverse events related to the use of the QuantumLeap device was documented.

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Posted

Count of Participants

Participants

From the time of dosing through the follow-up visit, up to 10 days

ID	Title	Description
OG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.
OG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Secondary

Number of Participants With Adverse Events Related to the Use of the Radiance Device

The number of participants with adverse events related to the use of the Radiance device was documented.

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Posted

Count of Participants

Participants

From the time of dosing through the follow-up visit, up to 10 days

ID	Title	Description
OG000	Normal-CKD Stage 2/Radiance	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG001	CKD Stage 3-5/Radiance	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Units	Counts

Secondary

Number of Participants With Adverse Events Related to the Use of the Brilliance Device

The number of participants with adverse events related to the use of the Brilliance device was documented.

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Posted

Count of Participants

Participants

From the time of dosing through the follow-up visit, up to 10 days

ID	Title	Description
OG000	Normal-CKD Stage 2/Brilliance Algorithm Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG001	CKD Stage 3-5/Brilliance Algorithm Optimization	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Normal-CKD Stage 2/QuantumLeap	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.	31	31	7	31
EG001	CKD Stage 3-4/QuantumLeap	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.	29	29	5	29
EG002	Normal-CKD Stage 2/Radiance	MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	20	20	2	20
EG003	CKD Stage 3-5/Radiance	MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	40	40	0	40
EG004	Normal-CKD Stage 2/Brilliance Algorithm Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	9	9	1	9
EG005	CKD Stage 3-5/Brilliance Algorithm Optimization	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	7	7	1	7
EG006	Normal-CKD Stage 2/Brilliance Sensor Optimization	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	18	18	2	18
EG007	Normal-CKD Stage 2/Brilliance Sensor Validation	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	30	30	0	30
EG008	CKD Stage 3-5/Brilliance Sensor Validation	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	18	18	1	18
EG009	Normal-CKD Stage 2/Brilliance (1-2 Sensors)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.	12	12	2	12
EG010	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart. MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart: 130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. Brilliance (1 or 2 sensors): Optical Renal Function Monitor (ORFM) Brilliance (2-part sensor): Optical Renal Function Monitor (ORFM)	4	4	1	4
EG011	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	4	4	1	4
EG012	CKD Stage 3-5/Brilliance 1-2 Sensors	MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	12	12	2	12

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk EG0020 affected20 at risk EG0030 affected40 at risk EG0040 affected9 at risk EG0050 affected7 at risk EG0060 affected18 at risk EG0070 affected30 at risk EG0080 affected18 at risk EG0090 affected12 at risk EG0100 affected4 at risk EG0110 affected4 at risk EG0120 affected12 at risk
Application site discoloration	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0010 affected29 at risk EG0020 affected20 at risk EG003
Application site erythema	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk EG0021 affected20 at risk EG003
Injection site bruising	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected31 at risk EG0011 affected29 at risk EG0020 affected20 at risk EG003
Injection site extravasation	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0010 affected29 at risk EG0020 affected20 at risk EG003
Oedema peripheral	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk EG0020 affected20 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0010 affected29 at risk EG0021 affected20 at risk EG003
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected31 at risk EG0011 affected29 at risk EG0020 affected20 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0010 affected29 at risk EG0020 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk EG0020 affected20 at risk EG003
Hot flush	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected31 at risk EG0010 affected29 at risk EG0020 affected20 at risk EG003

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D014283	Triiodobenzoic Acids
D007463	Iodobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons