Pharmacokinetics and Safety of MB-102 (Relmapirazin) and... | NCT05425719

NCT05425719

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
eGFR ≥ 70 mL/min/1.73 m^2	Experimental	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.	Drug: MB-102 Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
eGFR < 70 mL/min/1.73 m^2	Experimental	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.	Drug: MB-102 Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MB-102	Drug	18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values	The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.	Up to 24 hours following the study dose

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization
Men will not donate sperm during the study and for 1 month following the last dose of study drug
Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
Adequate venous access sufficient to allow blood sampling per protocol requirements

Exclusion Criteria:

Participants positive via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)
Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
Participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer)
History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 or other related products (intolerance to a drug is not considered a drug allergy).
Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
Significant scarring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin
Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the participant at increased risk or compromise the interpretability of study results.
Currently receiving dialysis
Currently anuric
Positive serum pregnancy test
Participants with an eGFR > 120 mL/min/1.73m^2

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Velocity Clinical Research		Edgewater	Florida	32132	United States
Research by Design, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37104481	Derived	Chan G, Pino CJ, Johnston KA, Humes HD. Estimating Changes in Glomerular Filtration Rate With Fluorescein Isothiocyanate-Sinistrin During Renal Replacement Therapy. ASAIO J. 2023 Aug 1;69(8):810-815. doi: 10.1097/MAT.0000000000001947. Epub 2023 Apr 27.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
FG001	eGFR < 70 mL/Min/1.73 m^2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 20, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

eGFR < 70 mL/min/1.73 m^2

eGFR ≥ 70 mL/min/1.73 m^2

Safety Population: all subjects who enrolled in the study and were dosed with MB-102

Arm/Group Information

ID	Title	Description
BG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
BG001	eGFR < 70 mL/Min/1.73 m^2	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000130 BG001119 BG002249

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.9± 14.19 BG00161.5± 13.45 BG00253.9± 15.63

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00145 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00036 BG00114 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values

The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.

Modified intent-to-treat population (all participants enrolled in the study for whom an average session tGFR had been calculated, with no major protocol deviations and no outlier pharmacokinetic parameters)

Posted

Number

95% Confidence Interval

Proportion of tGFR within 30% of nGFR

Up to 24 hours following the study dose

ID	Title	Description
OG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
OG001	eGFR < 70 mL/Min/1.73 m^2	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.
OG002	All Participants	Participants received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 - 24 hours.

Units	Counts
Participants	OG00090 OG00192 OG002182

Title

Denominators

Categories

Title	Measurements
	OG0000.96(0.89 to 0.99) OG0010.92(0.85 to 0.97) OG0020.94(0.89 to 0.97)

Secondary

Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration

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

Safety Population: all participants who enrolled in the study and were dosed with MB-102

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
OG001	eGFR < 70 mL/Min/1.73 m^2	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.

Units	Counts

Secondary

Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device

Safety Population: all participants who enrolled in the study and were dosed with MB-102

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
OG001	eGFR < 70 mL/Min/1.73 m^2	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	eGFR ≥ 70 mL/Min/1.73 m^2	Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.	0	130	0	130	3	130
EG001	eGFR < 70 mL/Min/1.73 m^2	Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.	0	119	0	119	7	119

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac murmur	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected130 at risk EG0012 affected119 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected130 at risk EG0011 affected119 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected130 at risk EG0012 affected119 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected130 at risk EG0012 affected119 at risk

First MCP Posted Date

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000657342	relmapirazin