Kidney DiseasesPhase 3NCT05943977
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants
A Phase 3 study testing MB-102 DMID, MB-102 OMID and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Kidney Diseases and Kidney Injury, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Kidney Injury, Kidney Failure
- What is being tested?
- MB-102 DMID, MB-102 OMID and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesChina
- Study dates
- 2 Mar 2023to 30 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bioequivalence study:
- The participant is aged 18-55 years, inclusive, at the date of informed consent
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial and at least 1 month post-dose
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 1 month 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 during the trial and at least 1 month post-dose, 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
- The participant weighs at least 50 kg, and has a body mass index (BMI) between 19 and 25 kg/m2, inclusive, at Screening
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- The participant is a Chinese healthy adult male or female
- 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
- Efficacy study:
- Age > 18 years - male or female
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial and at least 1 month post-dose
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 1 month 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 during the trial and at least 1 month post-dose, 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
Who cannot join
- Bioequivalence study:
- Participants positive via PCR testing for COVID-19
- 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.
- The 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 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).
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- Participants with positive serum pregnancy test
- The participant has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or prior to the study drug administration in Period 1
- The participant has abnormal laboratory values that suggest a clinically significant underlying disease, or subject with the following abnormalities at Screening or prior to the study drug administration in Period 1: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 x the upper limits of normal (ULN)
- History of drug and/or alcohol abuse within the past year.
- Participants with a creatine kinase (CK) value of greater than the upper limit of normal that is not explainable by exercise and that does not come back to reference range upon retest;
- Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the participant from safely participating in the study.
- Efficacy study:
- Participants positive via PCR testing for COVID-19
- 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 medicatio
- Non-steroidal anti-inflammatory (NSAID) use within 3days of MB-102 dosing.
- The 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 such as acute or chronic medical condition or cardiac or laboratory or physical examination abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of the study results in the judgement of the investigator and would make the subject inappropriate for entry into this study.
- 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
- Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day; Use of makeup, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing
- 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 participants' 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
- Participants with positive serum pregnancy test
- Participants with an eGFR >120 mL/min/1.73m2 or <15 mL/min/1.73m2
Trial locations and contacts
2 sites in 1 country.
China2 sites
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215008
Affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: A Randomized, Open Label, 2-Period, Cross-over Study to Evaluate the Bioequivalence of the Oversea Manufactured Sample and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) (Part I), and an Efficacy Study to Assess the Performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese Normal and Renal Compromised Subjects (Part II)
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants.
Read the detailed description
Part I (bioequivalence) will be conducted as an open-label, 2-period, 2-treatment, crossover study with 24 subjects expected to enroll. Blood and urine samples will be collected. Part II (efficacy) will enroll up to 100 subjects, divided into 2 strata (1:1) in accordance with screening eGFR measured by the CKD-EPI equation. Blood samples will be collected at predefined time points and the MediBeacon Transdermal GFR Measurement System will be used to collect fluorescent measurements.
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Being tested
- MB-102 DMID, MB-102 OMID, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Keywords
- Glomerular Filtration Rate, Relmapirazin, Pharmacokinetics, MB-102
- Medical subject headings
- Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-102 DMIDDrug
Also called Relmapirazin
130 mg of the MB-102 Domestic Manufactured Investigational Drug administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds.
MB-102 OMIDDrug
Also called Relmapirazin
130 mg of the MB-102 Overseas Manufactured Investigational Drug (OMID) administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds.
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)Device
On treatment day, participants will have the TGFR sensor placed on their chests, and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements terminated by the system when a low signal-to-noise threshold is reached.
| Study group | Role | What they receive |
|---|---|---|
| 130 mg MB-102 DMID, then 130 mg MB 102-OMID | Experimental | Participants will receive a single 130 mg dose of the MB-102 Domestic Manufactured Investigational Drug (DMID), and blood and urine samples will be collected per protocol. There will be a 5-day washout period between treatments, and then participants will receive a single 130 mg dose of the MB-102 Overseas Manufactured Investigational Drug (OMID). Blood and urine samples will be collected per protocol Receives: Drug: MB-102 DMID; Drug: MB-102 OMID |
| 130 mg MB-102 OMID, then 130 mg MB 102-DMID | Experimental | Participants will receive a single 130 mg dose of the MB-102 Overseas Manufactured Investigational Drug (OMID), and blood and urine samples will be collected per protocol. There will be a 5-day washout period between treatments, and then participants will receive a single 130 mg dose of the MB-102 Domestic Manufactured Investigational Drug (DMID). Blood and urine samples will be collected per protocol. Receives: Drug: MB-102 DMID; Drug: MB-102 OMID |
| Participants with eGFR ≥ 70 mL/min/1.73 m^2 | Experimental | 130 mg of the MB-102 Domestic Manufactured Investigational Drug (DMID) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System Receives: Drug: MB-102 DMID; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) |
| Participants with eGFR < 70 mL/min/1.73 m^2 | Experimental | 130 mg of the MB-102 Domestic Manufactured Investigational Drug (DMID)will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System Receives: Drug: MB-102 DMID; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) from time 0 to infinity will be calculated as: AUC0-last+Clast//λz where Clast is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)
Statistical agreement between tGFR and nGFR will be calculated using P30 statistics
Measured: Up to 24 hours
Secondary outcomes (9)
Maximum Plasma Concentration (Cmax) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods.Maximum plasma concentration (Cmax; measured in ng/mL) will be directly determined from the concentration-time data.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MB-102 (AUC0-last)
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods.The area under the plasma concentration-time curve (ng*hr/mL) will be estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
The terminal rate constant (Lambda_z) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. The terminal rate constant (λz) will be determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Total plasma clearance (CL) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) will be calculated as: Clp = Dose/ AUC0-inf.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Volume of distribution (Vd) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. Volume of distribution will be calculated by Vd=CL/λz
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
The elimination half-life of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be 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) will be calculated as t1/2 λz= ln(2)/ λz.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Time to Maximum Plasma Concentration (Tmax) of MB-102
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods.The time to maximum plasma concentration (Tmax; measured in minutes) will be directly determined from the concentration-time data.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Area under the plasma concentration-time curve extrapolated as a percentage of the total (AUC_%Extrap)
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. AUC_%Extrap will be calculated as (AUC0-inf-AUC0-last)/AUC0-inf *100%.
Measured: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device
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
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start2 Mar 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MediBeacon
- Responsible party
- Sponsor
- Investigators
- Yuanyuan Luo, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityDong Sun, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityYanxia Yu, Principal investigator, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943977
- Sponsor's protocol ID
- HDNP102-301
- Other IDs
- CTR20230300
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 2-Period, Cross-over Study to Evaluate the Bioequivalence of the Oversea Manufactured Sample and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) (Part I), and an Efficacy Study to Assess the Performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese Normal and Renal Compromised Subjects (Part II)
- ClinicalTrials.gov ID
- NCT05943977
- Acronym / sponsor ID
- HDNP102-301
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Keywords
- Glomerular Filtration Rate, Relmapirazin, Pharmacokinetics, MB-102
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- MediBeacon
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants.
Detailed description
Part I (bioequivalence) will be conducted as an open-label, 2-period, 2-treatment, crossover study with 24 subjects expected to enroll. Blood and urine samples will be collected. Part II (efficacy) will enroll up to 100 subjects, divided into 2 strata (1:1) in accordance with screening eGFR measured by the CKD-EPI equation. Blood samples will be collected at predefined time points and the MediBeacon Transdermal GFR Measurement System will be used to collect fluorescent measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 130 mg MB-102 DMID, then 130 mg MB 102-OMID | Experimental | Drug: MB-102 DMID, Drug: MB-102 OMIDParticipants will receive a single 130 mg dose of the MB-102 Domestic Manufactured Investigational Drug (DMID), and blood and urine samples will be collected per protocol. There will be a 5-day washout period between treatments, and then participants will receive a single 130 mg dose of the MB-102 Overseas Manufactured Investigational Drug (OMID). Blood and urine samples will be collected per protocol |
| 130 mg MB-102 OMID, then 130 mg MB 102-DMID | Experimental | Drug: MB-102 DMID, Drug: MB-102 OMIDParticipants will receive a single 130 mg dose of the MB-102 Overseas Manufactured Investigational Drug (OMID), and blood and urine samples will be collected per protocol. There will be a 5-day washout period between treatments, and then participants will receive a single 130 mg dose of the MB-102 Domestic Manufactured Investigational Drug (DMID). Blood and urine samples will be collected per protocol. |
| Participants with eGFR ≥ 70 mL/min/1.73 m^2 | Experimental | Drug: MB-102 DMID, Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)130 mg of the MB-102 Domestic Manufactured Investigational Drug (DMID) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System |
| Participants with eGFR < 70 mL/min/1.73 m^2 | Experimental | Drug: MB-102 DMID, Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)130 mg of the MB-102 Domestic Manufactured Investigational Drug (DMID)will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The participant is aged 18-55 years, inclusive, at the date of informed consent
- The participant weighs at least 50 kg, and has a body mass index (BMI) between 19 and 25 kg/m2, inclusive, at Screening
- The participant is a Chinese healthy adult male or female
- 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
Key exclusion criteria (27 listed)
- Participants positive via PCR testing for COVID-19
- 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.
- The 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 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-102 DMIDAlso: Relmapirazin130 mg of the MB-102 Domestic Manufactured Investigational Drug administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds. | Drug | 130 mg MB-102 DMID, then 130 mg MB 102-OMID, 130 mg MB-102 OMID, then 130 mg MB 102-DMID, Participants with eGFR < 70 mL/min/1.73 m^2, Participants with eGFR ≥ 70 mL/min/1.73 m^2 |
| MB-102 OMIDAlso: Relmapirazin130 mg of the MB-102 Overseas Manufactured Investigational Drug (OMID) administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered over 30-60 seconds. | Drug | 130 mg MB-102 DMID, then 130 mg MB 102-OMID, 130 mg MB-102 OMID, then 130 mg MB 102-DMID |
| MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)On treatment day, participants will have the TGFR sensor placed on their chests, and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements terminated by the system when a low signal-to-noise threshold is reached. | Device | Participants with eGFR < 70 mL/min/1.73 m^2, Participants with eGFR ≥ 70 mL/min/1.73 m^2 |
Primary outcome
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Blood samples will be collected pre-dose (within 60 minutes prior to dosing) and at 5 min, 15 min, 30 min, 60 min, 90 min (±2 min), 2h, 3h, 4h, 5h, 6h, 8h, 10h , 12h, 16h, 20h and 24h (±5 min) post-dose, and will be analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) from time 0 to infinity will be calculated as: AUC0-last+Clast//λz where Clast is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)
Time frame: Up to 24 hours
Statistical agreement between tGFR and nGFR will be calculated using P30 statistics
9 secondary outcomes
Maximum Plasma Concentration (Cmax) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MB-102 (AUC0-last)
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
The terminal rate constant (Lambda_z) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Total plasma clearance (CL) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Volume of distribution (Vd) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
The elimination half-life of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Time to Maximum Plasma Concentration (Tmax) of MB-102
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Area under the plasma concentration-time curve extrapolated as a percentage of the total (AUC_%Extrap)
Time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanyuan Luo principal investigator
The Affiliated Hospital of Xuzhou Medical University
Dong Sun principal investigator
The Affiliated Hospital of Xuzhou Medical University
Yanxia Yu principal investigator
Suzhou Municipal Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MB-102 DMID, MB-102 OMID and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Kidney Diseases and Kidney Injury, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MB-102 (time frame: Pre-dose (within 60 minutes prior to dosing) and at 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes (±2 minutes), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours (±5 minutes) post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.