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

• Study Type: Interventional
• Enrollment (Estimated): 131
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ruowen Guo; Phone Number: +86 0571-85233836; Email: ruowen.guo@mindrank.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First hospital of Jilin University
      • Contact: Yanhua Ding
      • Contact: Guixia Wang

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.
• Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.
• For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.

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.
• Serum calcitonin > ULN at screening.
• Participants with systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening.
• Participants with ALT >2 × ULN and /or AST > 2 × ULN at screening.
• Participants whose fasting triglycerides > 5.7 mmol/L, total cholesterol > 7.75 mmol/L, low-density lipoprotein cholesterol > 4.9 mmol/L at screening.
• Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).
• Participants with fasting blood glucose levels > 7 mmol/L.
• Participants with creatinine clearance < 60 mL/min at screening [calculation formula: CLcr: (140 - age) × weight (kg) / [72 × 0.0113 × Scr (μmol/L)], × 0.85 for females].
• Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.
• Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values > 450 ms for male participants or > 470 ms for female participants.

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 (Estimated): July 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; 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