A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants

A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants

To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.

Study Overview

• Status: Completed
• Conditions: Overweight and Obese Volunteers
• Intervention / Treatment: Drug: MDR-001; Drug: palcebo

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

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

Description

Main inclusion criteria:

• Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent, no gender restriction.
• Participants with body weight ≥ 50 kg for males, and ≥ 45 kg for females; 18 ≤ body mass index (BMI) < 25 kg/m2 for healthy participants, and 25 ≤ BMI ≤ 35 kg/m2 for obese/overweight participants.
• For healthy participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant. For obese/overweight participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant, and the vital signs should be within following ranges: systolic blood pressure: 90-150 mmHg; diastolic blood pressure: 50-95 mmHg.

Main exclusion criteria:

• Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.
• Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.
• Participants with a history of pancreatitis or symptomatic gallbladder disease.
• Participants with serum calcitonin levels above the upper limit of normal (ULN) at screening.
• Participants with significant changes in diet or exercise habits within 3 months prior to screening.
• Participants with clinically significant electrocardiogram abnormality; or ECG QTcF values > 450 ms for males or > 470 ms for females.
• Participants with clinically significant abnormalities in laboratory examinations (obese/overweight participants with triglycerides ≤ 5.7 mmol/L, total cholesterol ≤ 7.75 mmol/L, low-density lipoprotein cholesterol ≤ 4.9 mmol/L, and fasting blood glucose ≤ 7 mmol/L can be included); or those with clinically significant findings indicating the following diseases within 12 months prior to screening, including but not limited to disorders of respiratory system, circulatory system, digestive system, endocrine system, rheumatological/immune system, nervous system, and blood system, and mental/psychological disorders, which are considered by the investigator as inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDR-001（SAD）; Single doses of MDR-001 administered orally.	Drug: MDR-001; Oral administration of small molecule MDR-001 tablets
Experimental: Placebo (SAD); Placebo administered orally.	Drug: palcebo; Administered orally placebo
Experimental: MDR-001 (MAD); Multiple doses of MDR-001 administered orally.	Drug: MDR-001; Oral administration of small molecule MDR-001 tablets
Experimental: Placebo (MAD); Placebo administered orally.	Drug: palcebo; Administered orally placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001	PK: AUC of MDR-001	Baseline through Day 84
Change from Baseline in Fasting Glucose	Change from Baseline in Fasting Glucose	Baseline through Day 84
Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001	PK: Cmax of MDR-001	Baseline through Day 84
Change from Baseline in Glycated Hemoglobin (HbA1c)	Change from Baseline in HbA1c	Baseline through Day 84
Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline through Day 84

Collaborators and Investigators

• Sponsor: MindRank AI Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: MDR-001-CN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No