Overview
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.
Eligibility
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.