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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Stage: HRS9531 | Experimental | Administered po once |
|
| SAD Stage: placebo | Placebo Comparator | Administered po once |
|
| MAD Stage: HRS9531 | Experimental | Administered po for multiple dose |
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| MAD Stage: placebo | Placebo Comparator | Administered po for multiple dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | Single dose escalation of HRS9531 tablets in healthy subjects |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SAD Stage: Number of Adverse Events | 36 days | |
| MAD Stage: Number of Adverse Events | 63 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration-Time to Peak (Tmax) of HRS9531 | Tmax of a single dose of HRS9531 tablets | 36 days |
| Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531 | AUC of a single dose of HRS9531 tablets |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital Of Anhui medical University | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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randomized, double-blind, placebo-controlled
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| Placebo |
| Drug |
Single dose of placebo in healthy adults |
|
| HRS9531 | Drug | Multiple dose escalation of HRS9531 tablets in healthy subjects |
|
| Placebo | Drug | Multiple dose of placebo in healthy adults |
|
| 36 days |
| Immunogenicity qualitative | anti-HRS9531 antibody | 36 days |
| Plasma Concentration-Time to Peak (Tmax) of HRS9531 | Tmax of multiple dose of HRS9531 tablets | 63 days |
| Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531 | AUC of multiple dose of HRS9531 tablets | 63 days |
| Glucose | fasting plasma glucose | 35 days |
| Immunogenicity qualitative | anti-HRS9531 antibody | 63 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |