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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose escalation of HRS9531 injection in healthy subjects | Experimental |
| |
| Single dose of placebo in healthy adults | Placebo Comparator |
| |
| Multiple dose escalation of HRS9531 injection in healthy subjects | Experimental |
| |
| Multiple dose of placebo in healthy adults | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | Administered SC once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | A summary of adverse events, including Serious Adverse Events(SAEs) | Start of Treatment to end of study (approximately 7 weeks or 9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of HRS9531 | AUC of HRS9531 after single subcutaneous injection | Start of Treatment to end of study (approximately 7 weeks) |
| Immunogenicity qualitative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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HRS9531 compared with placebo
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| placebo |
| Other |
Administered SC once |
|
| HRS9531 | Drug | Administered SC for multiple dose |
|
| placebo | Other | Administered SC for multiple dose |
|
anti-HRS9531 antibody
| Start of Treatment to end of study (approximately 7 weeks) |
| AUC of HRS9531 | AUC of HRS9531 after multiple subcutaneous injections | Start of Treatment to end of study (approximately 9 weeks) |
| Immunogenicity qualitative | anti-HRS9531 antibody | Start of Treatment to end of study (approximately 9 weeks) |
| Glucose concentration | fasting plasma glucose | Start of Treatment to end of study (approximately 9 weeks) |
| D004700 | Endocrine System Diseases |