Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment

A Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of MDR-001 Tablets in Patients With Mild and Moderate Hepatic Impairment and Matched Participants With Normal Hepatic Function

This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched healthy controls. The study aims to evaluate the pharmacokinetics and safety of MDR-001 in these populations. Primary pharmacokinetic endpoints include AUC and Cmax; safety endpoints include adverse events, vital signs, ECG, and laboratory assessments.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B); Hepatic Insufficiency (MeSH ID: D048550)
• Intervention / Treatment: Drug: MDR-001

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guodong Li, PhD; Phone Number: +86 18968027256; Email: guodong.li@mindrank.cn
• Study Contact Backup: Name: Weixia Li, MD; Phone Number: +86 15000279084; Email: weixia.li@mindrank.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
      • Contact: Hong Zhang, MD; Phone Number: +86 13654376192; Email: jhongzhang@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntary signed informed consent before any study-related activities, and ability to understand the study procedures and methods, and willingness to strictly comply with the protocol to complete the study.
2. Participants (including their partners) must have no pregnancy plan and voluntarily take effective contraceptive measures from screening until 6 months after study drug administration.
3. Age 18 to 70 years (inclusive), male or female.
4. Male body weight ≥50 kg, female body weight ≥45 kg; body mass index (BMI) between 18 and 32 kg/m² (inclusive).
5. Estimated glomerular filtration rate (eGFR, calculated by CKD-EPI formula) ≥60 mL/min/1.73m².

6. Additional criteria for participants with hepatic impairment:

   • Chronic liver injury caused by primary liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.).
   • Child-Pugh grade A or B (see Appendix 1); recent liver function and complications stable, no significant deterioration (e.g., abdominal pain, increased ascites, nausea, vomiting, anorexia, fever, or worsening of liver-related laboratory results).
   • Stable medication regimen (including type, dose, or frequency) for the treatment of hepatic impairment, complications, or other concomitant diseases for at least 14 days before study drug administration, with no need for adjustment (diuretics and insulin, etc., excepted); or not taking any such medications.

Exclusion Criteria:

1. Allergic constitution, including severe drug allergy or history of drug anaphylaxis; known allergy to the study drug or any of its components.
2. Screening ECG showing QTcF >450 msec (males) or >470 msec (females) (Fridericia correction); personal or family history of long QT syndrome; family history (parents, children, siblings) of sudden death before age 40; and/or personal history of unexplained syncope within 1 year before screening.
3. Dysphagia or any gastrointestinal disease affecting drug absorption, including frequent nausea or vomiting from any cause; active peptic ulcer; constipation.
4. Within 6 months before screening: severe gastrointestinal disease (e.g., active ulcer) or gastrointestinal surgery (except appendectomy, cholecystectomy, or other endoscopic procedures judged not to significantly affect gastrointestinal motility); clinically significant gastric emptying abnormality (e.g., pyloric obstruction, gastroparesis).
5. Any symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening (except hepatitis B or C); history of serious active infection within 1 month before screening.
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or genetic disorders predisposing to medullary thyroid carcinoma.
7. Blood donation or blood loss ≥400 mL within 3 months before screening, or planned blood donation during the study or within 1 month after study completion.
8. Use of another investigational drug within 3 months before screening, or planned participation in another clinical study during this study.
9. Use of CYP3A4 inhibitors/inducers or P-gp inhibitors within 14 days before first dose, or planned use during the study.
10. Pregnant or breastfeeding women, or positive pregnancy test.
11. History of depression or other serious mental disorders (e.g., schizophrenia, bipolar disorder, or other severe mood or anxiety disorders); history of suicidal ideation or suicidal behavior.
12. Any other reason judged by the investigator as unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Mild hepatic impairment	Drug: MDR-001; Participants receive a single oral dose of MDR-001
Experimental: Cohort B: Moderate hepatic impairment	Drug: MDR-001; Participants receive a single oral dose of MDR-001
Experimental: Cohort C: Matched normal hepatic function	Drug: MDR-001; Participants receive a single oral dose of MDR-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary pharmacokinetic (PK) parameters of MDR-001	Maximum observed plasma concentration (Cmax) of MDR-001 following a single oral dose.	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Primary pharmacokinetic (PK) parameters of MDR-001	Area under the plasma concentration curve from time 0 to the last quantifiable concentration (AUC0-t) MDR-001 following a single dose	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Primary pharmacokinetic (PK) parameters of MDR-001	Area under the plasma concentration time curve from time 0 to infinity (AUC 0-∞) of MDR-001 following a single dose	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary pharmacokinetic parameters	Time to peak concentration (Tmax)	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Secondary pharmacokinetic parameters	Terminal elimination half-life (t1/2)	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Secondary pharmacokinetic parameters	Clearance (CL/F),	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Secondary pharmacokinetic parameters	Apparent volume of distribution (Vz/F)	Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Collaborators and Investigators

• Sponsor: MindRank AI Ltd
• Investigators: Principal Investigator: Hong Zhang, MD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: safety; Open-label; Pharmacokinetics (PK); GLP-1 receptor agonist (GLP-1RA); Phase I clinical study; MDR-001; Hepatic impairment (mild, moderate); Child-Pugh A / Child-Pugh B; Matched healthy controls
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Liver Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Hepatic Insufficiency
• Other Study ID Numbers: MDR-001-CN-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No