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.
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.
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.
Parallel
MDR-001
DrugOral administration of small molecule MDR-001 tablets
palcebo
DrugAdministered orally placebo
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001
PK: AUC of MDR-001
Change from Baseline in Fasting Glucose
Change from Baseline in Fasting Glucose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001
PK: Cmax of MDR-001
Change from Baseline in Glycated Hemoglobin (HbA1c)
Change from Baseline in HbA1c
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