A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants

NCT ID: NCT05943977

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2023-11-30

Brief 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. 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.

Conditions

Kidney Diseases; Kidney Injury; Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

130 mg MB-102 DMID, then 130 mg MB 102-OMID

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

Group Type: EXPERIMENTAL

MB-102 DMID

Intervention Type: DRUG

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 OMID

Intervention Type: DRUG

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.

130 mg MB-102 OMID, then 130 mg MB 102-DMID

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.

Group Type: EXPERIMENTAL

MB-102 DMID

Intervention Type: DRUG

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 OMID

Intervention Type: DRUG

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.

Participants with eGFR ≥ 70 mL/min/1.73 m^2

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

Group Type: EXPERIMENTAL

MB-102 DMID

Intervention Type: DRUG

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.

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Intervention Type: 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.

Participants with eGFR < 70 mL/min/1.73 m^2

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

Group Type: EXPERIMENTAL

MB-102 DMID

Intervention Type: DRUG

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.

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Intervention Type: 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.

Interventions

MB-102 DMID

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.

Intervention Type: DRUG

MB-102 OMID

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Relmapirazin; Relmapirazin

Eligibility Criteria

Inclusion Criteria

Bioequivalence study:

1. The participant is aged 18-55 years, inclusive, at the date of informed consent

1. 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

2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 1 month post-dose

3. 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

2. The participant weighs at least 50 kg, and has a body mass index (BMI) between 19 and 25 kg/m2, inclusive, at Screening

3. The participant is a Chinese healthy adult male or female

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

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

6. Adequate venous access sufficient to allow blood sampling per protocol requirements

Efficacy study:

1. Age > 18 years - male or female

1. 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

2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 1 month post-dose

3. 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

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

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

3. Adequate venous access sufficient to allow blood sampling per protocol requirements

Exclusion Criteria

Bioequivalence study:

1. Participants positive via PCR testing for COVID-19

2. 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

3. Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing.

4. 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).

5. 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).

6. Participants with positive serum pregnancy test

7. The participant has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or prior to the study drug administration in Period 1

8. 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)

9. History of drug and/or alcohol abuse within the past year.

10. 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;

11. 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:

1. Participants positive via PCR testing for COVID-19

2. 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

3. Non-steroidal anti-inflammatory (NSAID) use within 3days of MB-102 dosing.

4. 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).

5. History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)

6. 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).

7. 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.

8. 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

9. 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

10. 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.

11. Currently receiving dialysis

12. Currently anuric

13. Participants with positive serum pregnancy test

14. Participants with an eGFR >120 mL/min/1.73m2 or <15 mL/min/1.73m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MediBeacon

INDUSTRY

Sponsor Role: collaborator

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuanyuan Luo

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Dong Sun

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Yanxia Yu

Role: PRINCIPAL_INVESTIGATOR

Suzhou Municipal Hospital

Locations

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

CTR20230300

Identifier Type: REGISTRY

Identifier Source: secondary_id

HDNP102-301

Identifier Type: -

Identifier Source: org_study_id