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

MindRank AI Ltd

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Overweight and Obese Volunteers

Treatments: Drug: palcebo; Drug: MDR-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06778850

MDR-001-CN-01

Details and patient eligibility

About

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.

Enrollment: 131 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 4 patient groups

MDR-001（SAD）

Experimental group

Description:

Single doses of MDR-001 administered orally.

Treatment:

Drug: MDR-001

Placebo (SAD)

Experimental group

Description:

Placebo administered orally.

Treatment:

Drug: palcebo

MDR-001 (MAD)

Experimental group

Description:

Multiple doses of MDR-001 administered orally.

Treatment:

Drug: MDR-001

Placebo (MAD)

Experimental group

Description:

Placebo administered orally.

Treatment:

Drug: palcebo