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

NCT ID: NCT06778850

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MDR-001（SAD）

Single doses of MDR-001 administered orally.

Group Type: EXPERIMENTAL

MDR-001

Intervention Type: DRUG

Oral administration of small molecule MDR-001 tablets

Placebo (SAD)

Placebo administered orally.

Group Type: EXPERIMENTAL

palcebo

Intervention Type: DRUG

Administered orally placebo

MDR-001 (MAD)

Multiple doses of MDR-001 administered orally.

Group Type: EXPERIMENTAL

MDR-001

Intervention Type: DRUG

Oral administration of small molecule MDR-001 tablets

Placebo (MAD)

Placebo administered orally.

Group Type: EXPERIMENTAL

palcebo

Intervention Type: DRUG

Administered orally placebo

Interventions

MDR-001

Oral administration of small molecule MDR-001 tablets

Intervention Type: DRUG

palcebo

Administered orally placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MindRank AI Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruowen Guo

Role: CONTACT

ruowen.guo@mindrank.cn

+86 0571-85233836

Facility Contacts

Yanhua Ding

Role: primary

Guixia Wang

Role: backup

Other Identifiers

MDR-001-CN-01

Identifier Type: -

Identifier Source: org_study_id