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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDR-001(SAD) | Experimental | Single doses of MDR-001 administered orally. |
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| Placebo (SAD) | Experimental | Placebo administered orally. |
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| MDR-001 (MAD) | Experimental | Multiple doses of MDR-001 administered orally. |
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| Placebo (MAD) | Experimental | Placebo administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDR-001 | Drug | Oral administration of small molecule MDR-001 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline through Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001 | PK: AUC of MDR-001 | Baseline through Day 84 |
| Change from Baseline in Fasting Glucose | Change from Baseline in Fasting Glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruowen Guo | Contact | +86 0571-85233836 | ruowen.guo@mindrank.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| palcebo | Drug | Administered orally placebo |
|
| Baseline through Day 84 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001 | PK: Cmax of MDR-001 | Baseline through Day 84 |
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Change from Baseline in HbA1c | Baseline through Day 84 |
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline through Day 84 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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