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
Trial Parameters
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.
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 fastin