Trial Outcomes & Findings for Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types (NCT NCT02772276)

NCT ID: NCT02772276

Last Updated: 2023-10-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 234 participants
• Primary outcome timeframe: From the time of dosing through the follow-up visit, up to 10 days
• Results posted on: 2023-10-26

Participant Flow

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

Participant milestones

Measure	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	31	29	20	40	9	7	18	30	18	12	4	4	12
Overall Study COMPLETED	31	29	20	40	9	7	17	29	18	12	4	4	12
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	1	0	0	0	0	0

Reasons for withdrawal

Measure	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study Lost to Follow-up	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study Withdrew consent	0	0	0	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

Baseline characteristics by cohort

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.	Total n=234 Participants Total of all reporting groups
Age, Continuous	40.3 years STANDARD_DEVIATION 11.78 • n=5 Participants	58.2 years STANDARD_DEVIATION 11.76 • n=7 Participants	54.7 years STANDARD_DEVIATION 13.57 • n=5 Participants	61.1 years STANDARD_DEVIATION 12.93 • n=4 Participants	46.9 years STANDARD_DEVIATION 13.40 • n=21 Participants	66.9 years STANDARD_DEVIATION 6.67 • n=10 Participants	41.6 years STANDARD_DEVIATION 15.42 • n=115 Participants	39.1 years STANDARD_DEVIATION 15.38 • n=24 Participants	70.9 years STANDARD_DEVIATION 8.09 • n=42 Participants	47.9 years STANDARD_DEVIATION 17.70 • n=42 Participants	52.3 years STANDARD_DEVIATION 14.27 • n=42 Participants	42.5 years STANDARD_DEVIATION 13.72 • n=42 Participants	70.3 years STANDARD_DEVIATION 9.46 • n=36 Participants	53 years STANDARD_DEVIATION 16.7 • n=36 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	21 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants	8 Participants n=115 Participants	16 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=36 Participants	115 Participants n=36 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=10 Participants	10 Participants n=115 Participants	14 Participants n=24 Participants	12 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=36 Participants	119 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	7 Participants n=115 Participants	11 Participants n=24 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=36 Participants	87 Participants n=36 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	11 Participants n=115 Participants	19 Participants n=24 Participants	17 Participants n=42 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=36 Participants	144 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Region of Enrollment United States	31 Participants n=5 Participants	29 Participants n=7 Participants	20 Participants n=5 Participants	40 Participants n=4 Participants	9 Participants n=21 Participants	7 Participants n=10 Participants	18 Participants n=115 Participants	30 Participants n=24 Participants	18 Participants n=42 Participants	12 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	12 Participants n=36 Participants	234 Participants n=36 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events	7 Participants	7 Participants	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Maximum Plasma Concentration (Cmax) of MB-102	10751.613 ng/mL Standard Deviation 2279.3699	11625.517 ng/mL Standard Deviation 2491.4304	11981.7 ng/mL Standard Deviation 2659.9568	12243.45 ng/mL Standard Deviation 2563.5734	13961.111 ng/mL Standard Deviation 3326.5064	14440.143 ng/mL Standard Deviation 3049.767	13747.739 ng/mL Standard Deviation 2985.4673	13453.74 ng/mL Standard Deviation 3886.9335	13039.944 ng/mL Standard Deviation 3819.8448	13015.833 ng/mL Standard Deviation 2314.2462	15650 ng/mL Standard Deviation 4023.6799	13125 ng/mL Standard Deviation 2818.2441	11665 ng/mL Standard Deviation 3637.8803

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Maximum Plasma Concentration (Cmax) of Iohexol	295967.742 ng/mL Standard Deviation 71088.9039	290172.414 ng/mL Standard Deviation 74285.6788	333000 ng/mL Standard Deviation 70799.9405	329200 ng/mL Standard Deviation 98658.229	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Time to Maximum Plasma Concentration (Tmax) of MB-102	7.258 minutes Standard Deviation 5.2976	5.862 minutes Standard Deviation 2.341	5.25 minutes Standard Deviation 1.118	5.875 minutes Standard Deviation 2.2325	5 minutes Standard Deviation 0	6.429 minutes Standard Deviation 2.4398	6.111 minutes Standard Deviation 2.7416	5.167 minutes Standard Deviation 0.9129	12.222 minutes Standard Deviation 27.0197	5 minutes Standard Deviation 0	5 minutes Standard Deviation 0	5 minutes Standard Deviation 0	25 minutes Standard Deviation 67.7227

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Time to Maximum Plasma Concentration (Tmax) of Iohexol	9.194 minutes Standard Deviation 5.338	7.069 minutes Standard Deviation 3.1388	6.5 minutes Standard Deviation 2.3508	6.875 minutes Standard Deviation 2.7003	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
The Elimination Half-life of MB-102	130.712 minutes Standard Deviation 33.5894	314.267 minutes Standard Deviation 151.5375	135.821 minutes Standard Deviation 26.0772	301.21 minutes Standard Deviation 183.0147	123.681 minutes Standard Deviation 25.4325	245.7 minutes Standard Deviation 51.3774	140.176 minutes Standard Deviation 22.2139	122.86 minutes Standard Deviation 14.6245	305.944 minutes Standard Deviation 105.6855	126.049 minutes Standard Deviation 20.65	147.117 minutes Standard Deviation 23.779	127.842 minutes Standard Deviation 22.9881	440.488 minutes Standard Deviation 294.5741

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
The Elimination Half-life of Iohexol	148.056 minutes Standard Deviation 38.2236	366.529 minutes Standard Deviation 191.4136	151.776 minutes Standard Deviation 31.4044	347.574 minutes Standard Deviation 214.8895	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1131336.448 ng*min/mL Standard Deviation 254801.4255	2419911.379 ng*min/mL Standard Deviation 708114.7104	1211931.882 ng*min/mL Standard Deviation 296491.1469	2467846.174 ng*min/mL Standard Deviation 843410.9665	1121973.694 ng*min/mL Standard Deviation 190118.8591	2560133.925 ng*min/mL Standard Deviation 519858.5738	1235178.035 ng*min/mL Standard Deviation 310587.5336	1072786.062 ng*min/mL Standard Deviation 281421.3481	2476458.456 ng*min/mL Standard Deviation 543445.259	1384887.303 ng*min/mL Standard Deviation 345784.1469	1488269.994 ng*min/mL Standard Deviation 108723.6082	1316506.556 ng*min/mL Standard Deviation 314196.0436	3678411.381 ng*min/mL Standard Deviation 1344727.8138

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol	33329159.548 ng*min/mL Standard Deviation 7909842.8639	58097567.569 ng*min/mL Standard Deviation 15177720.419	36677146.278 ng*min/mL Standard Deviation 10789963.956	70005450.758 ng*min/mL Standard Deviation 30243153.821	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1166655.776 ng*min/mL Standard Deviation 298807.3587	3212036.698 ng*min/mL Standard Deviation 1490329.1808	1242760.175 ng*min/mL Standard Deviation 321230.0672	3045719.769 ng*min/mL Standard Deviation 1625406.4454	1182254.364 ng*min/mL Standard Deviation 208571.1669	2914852.088 ng*min/mL Standard Deviation 684490.5106	1264462.94 ng*min/mL Standard Deviation 333601.038	1086390.141 ng*min/mL Standard Deviation 287588.9895	3135394.594 ng*min/mL Standard Deviation 1051071.597	1403855.606 ng*min/mL Standard Deviation 355269.4445	1518516.431 ng*min/mL Standard Deviation 106177.2201	1340051.2 ng*min/mL Standard Deviation 332392.6494	3844963.027 ng*min/mL Standard Deviation 1630799.1909

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol	34688858.452 ng*min/mL Standard Deviation 9029243.5529	81061044.851 ng*min/mL Standard Deviation 37977572.641	38032869.839 ng*min/mL Standard Deviation 11788838.136	90107803.206 ng*min/mL Standard Deviation 61220389.979	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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∞.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Total Plasma Clearance of MB-102	110.719 mL/minute Standard Deviation 28.2476	51.741 mL/minute Standard Deviation 21.4424	102.361 mL/minute Standard Deviation 31.8835	51.322 mL/minute Standard Deviation 26.2932	103.107 mL/minute Standard Deviation 17.1532	44.677 mL/minute Standard Deviation 13.798	97.496 mL/minute Standard Deviation 18.6913	117.913 mL/minute Standard Deviation 39.4472	42.838 mL/minute Standard Deviation 13.1284	99.216 mL/minute Standard Deviation 33.0196	84.29 mL/minute Standard Deviation 5.0376	97.741 mL/minute Standard Deviation 23.5163	38.736 mL/minute Standard Deviation 13.87

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Total Plasma Clearance of Iohexol	97.596 mL/minute Standard Deviation 22.6026	47.418 mL/minute Standard Deviation 19.9867	90.788 mL/minute Standard Deviation 25.7641	45.963 mL/minute Standard Deviation 19.1755	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
The Terminal Rate Constant for MB-102	0.006 1/minutes Standard Deviation 0.0012	0.003 1/minutes Standard Deviation 0.001	0.005 1/minutes Standard Deviation 0.0009	0.003 1/minutes Standard Deviation 0.0012	0.006 1/minutes Standard Deviation 0.001	0.003 1/minutes Standard Deviation 0.0007	0.005 1/minutes Standard Deviation 0.0008	0.006 1/minutes Standard Deviation 0.0006	0.003 1/minutes Standard Deviation 0.0009	0.006 1/minutes Standard Deviation 0.0009	0.005 1/minutes Standard Deviation 0.0008	0.006 1/minutes Standard Deviation 0.0009	0.002 1/minutes Standard Deviation 0.0007

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
The Terminal Rate Constant for Iohexol	0.005 1/minutes Standard Deviation 0.001	0.002 1/minutes Standard Deviation 0.0009	0.005 1/minutes Standard Deviation 0.0009	0.002 1/minutes Standard Deviation 0.0008	—	—	—	—	—	—	—	—	—

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=17 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 Participants 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 Participants 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 Participants 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.
Renal Clearance of MB-102	111.396 mL/minute Standard Deviation 27.9973	52.171 mL/minute Standard Deviation 21.825	104.008 mL/minute Standard Deviation 32.3622	51.915 mL/minute Standard Deviation 26.3905	105.144 mL/minute Standard Deviation 19.2031	45.397 mL/minute Standard Deviation 14.1766	99.072 mL/minute Standard Deviation 19.0079	120.452 mL/minute Standard Deviation 40.0937	42.51 mL/minute Standard Deviation 12.9745	109.924 mL/minute Standard Deviation 35.5733	88.795 mL/minute Standard Deviation 3.2184	103.774 mL/minute Standard Deviation 24.9108	38.373 mL/minute Standard Deviation 13.0747

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	Normal-CKD Stage 2/Radiance n=20 Participants 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.	CKD Stage 3-5/Radiance n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Renal Clearance of Iohexol	98.548 mL/minute Standard Deviation 22.5239	47.909 mL/minute Standard Deviation 20.1816	92.258 mL/minute Standard Deviation 26.5401	46.109 mL/minute Standard Deviation 19.4391	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
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	-0.999 Coefficient of determination, r-squared Standard Deviation 0.0009	-0.998 Coefficient of determination, r-squared Standard Deviation 0.0028	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=20 Participants 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.	CKD Stage 3-4/QuantumLeap n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
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	-0.999 Coefficient of determination, r-squared Standard Deviation 0.001	-0.998 Coefficient of determination, r-squared Standard Deviation 0.0033	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=9 Participants 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.	CKD Stage 3-4/QuantumLeap n=18 Participants 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.	Normal-CKD Stage 2/Radiance n=30 Participants 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.	CKD Stage 3-5/Radiance n=12 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=4 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=4 Participants 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.	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.	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.	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.	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.	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.	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.	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.
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	-0.994 Coefficient of determination, r-squared Standard Deviation 0.0092	-0.998 Coefficient of determination, r-squared Standard Deviation 0.0026	-0.999 Coefficient of determination, r-squared Standard Deviation 0.0015	-0.997 Coefficient of determination, r-squared Standard Deviation 0.0037	-0.999 Coefficient of determination, r-squared Standard Deviation 0.0015	-1 Coefficient of determination, r-squared Standard Deviation 0.0001	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=7 Participants 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.	CKD Stage 3-4/QuantumLeap n=18 Participants 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.	Normal-CKD Stage 2/Radiance n=12 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
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 CKD Stage 3-4 Renal Function	-0.999 Coefficient of determination, r-squared Standard Deviation 0.0015	-0.998 Coefficient of determination, r-squared Standard Deviation 0.0018	-0.993 Coefficient of determination, r-squared Standard Deviation 0.0193	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

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

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

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=31 Participants 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.	CKD Stage 3-4/QuantumLeap n=29 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device	4 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

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

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

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=20 Participants 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.	CKD Stage 3-4/QuantumLeap n=40 Participants 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Number of Participants With Adverse Events Related to the Use of the Radiance Device	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

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

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

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

Outcome measures

Measure	Normal-CKD Stage 2/QuantumLeap n=9 Participants 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.	CKD Stage 3-4/QuantumLeap n=7 Participants 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.	Normal-CKD Stage 2/Radiance n=18 Participants 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.	CKD Stage 3-5/Radiance n=30 Participants 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=18 Participants 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=12 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=4 Participants 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=4 Participants 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.	CKD Stage 3-5/Brilliance Sensor Validation n=12 Participants 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.	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.	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.	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.	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.
Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

Adverse Events

Normal-CKD Stage 2/QuantumLeap

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

CKD Stage 3-4/QuantumLeap

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Radiance

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CKD Stage 3-5/Radiance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance Algorithm Optimization

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CKD Stage 3-5/Brilliance Algorithm Optimization

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance Sensor Optimization

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance Sensor Validation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CKD Stage 3-5/Brilliance Sensor Validation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance (1-2 Sensors)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CKD Stage 3-5/Brilliance 1-2 Sensors

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Normal-CKD Stage 2/QuantumLeap n=31 participants at risk 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.	CKD Stage 3-4/QuantumLeap n=29 participants at risk 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.	Normal-CKD Stage 2/Radiance n=20 participants at risk 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.	CKD Stage 3-5/Radiance n=40 participants at risk 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.	Normal-CKD Stage 2/Brilliance Algorithm Optimization n=9 participants at risk 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.	CKD Stage 3-5/Brilliance Algorithm Optimization n=7 participants at risk 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.	Normal-CKD Stage 2/Brilliance Sensor Optimization n=18 participants at risk 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.	Normal-CKD Stage 2/Brilliance Sensor Validation n=30 participants at risk 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.	CKD Stage 3-5/Brilliance Sensor Validation n=18 participants at risk 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors) n=12 participants at risk 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.	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) n=4 participants at risk 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)	Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 n=4 participants at risk 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.	CKD Stage 3-5/Brilliance 1-2 Sensors n=12 participants at risk 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.
Gastrointestinal disorders Nausea	6.5% 2/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
General disorders Application site discoloration	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	11.1% 2/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
General disorders Application site erythema	6.5% 2/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	5.0% 1/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
General disorders Injection site bruising	6.5% 2/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	3.4% 1/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
General disorders Injection site extravasation	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	5.6% 1/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	16.7% 2/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	25.0% 1/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	25.0% 1/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	8.3% 1/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
General disorders Oedema peripheral	3.2% 1/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	6.9% 2/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Infections and infestations Conjunctivitis	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	5.0% 1/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Nervous system disorders Headache	3.2% 1/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	3.4% 1/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	8.3% 1/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	25.0% 1/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	3.4% 1/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	14.3% 1/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Vascular disorders Hot flush	0.00% 0/31 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/29 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/20 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/40 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	11.1% 1/9 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/7 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/30 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/18 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/4 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/12 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days

Additional Information

Richard B Dorshow, PhD

MediBeacon

Phone: 314-735-0967

Email: rbdorshow@medibeacon.com

Results disclosure agreements

• Principal investigator is a sponsor employee MediBeacon requests that no presentation/publication occur until after the first publication of study results or until 1 yr after a study is completed/terminated early, whichever occurs first. Proposed results publication/disclosure must be given to Sponsor for review at least 45 days prior to the date of submission. If a patent application is to be filed, both the Institution and the Sponsor will defer publication or other disclosure for a period of time, not to exceed an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER