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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
The first hospital of Jilin University
Changchun, Jilin, China
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
Time frame: Baseline through Day 84
PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001
PK: AUC of MDR-001
Time frame: Baseline through Day 84
Change from Baseline in Fasting Glucose
Change from Baseline in Fasting Glucose
Time frame: Baseline through Day 84
Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001
PK: Cmax of MDR-001
Time frame: Baseline through Day 84
Change from Baseline in Glycated Hemoglobin (HbA1c)
Change from Baseline in HbA1c
Time frame: Baseline through Day 84
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Time frame: Baseline through Day 84
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