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.

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.