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

NCT06778850 | Recruiting Phase 1

• 1 other identifier: MDR-001-CN-01
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obese Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001

  Baseline through Day 84

• Change from Baseline in Fasting Glucose

  Baseline through Day 84

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001

  Baseline through Day 84

• Change from Baseline in Glycated Hemoglobin (HbA1c)

  Baseline through Day 84

• Change from Baseline in Body Weight

  Baseline through Day 84

Study Arms (4)

MDR-001（SAD）

EXPERIMENTAL

Single doses of MDR-001 administered orally.

Drug: MDR-001

Placebo (SAD)

EXPERIMENTAL

Placebo administered orally.

Drug: palcebo

MDR-001 (MAD)

EXPERIMENTAL

Multiple doses of MDR-001 administered orally.

Drug: MDR-001

Placebo (MAD)

EXPERIMENTAL

Placebo administered orally.

Drug: palcebo

Interventions

MDR-001 DRUG

Oral administration of small molecule MDR-001 tablets

MDR-001 (MAD); MDR-001（SAD）

palcebo DRUG

Administered orally placebo

Placebo (MAD); Placebo (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MindRank AI Ltd: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruowen Guo

CONTACT

+86 0571-85233836; ruowen.guo@mindrank.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: June 9, 2023
• Primary Completion: July 15, 2025
• Study Completion: December 30, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)