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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single and multiple doses in adults who are affected by obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5817 Injection Group | Experimental |
| |
| HRS-5817 Injection Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5817 Injection | Drug | HRS-5817 injection administered subcutaneously (SC). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Baseline up to Day 253. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the curve from time 0 to time t (AUC0-t) | 0 to anticipated 253 days. | |
| Area Under the curve from time 0 to infinity (AUC0-∞) | 0 to anticipated 253 days. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Feng | Contact | +86-0518-81220121 | sheng.feng@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical Uniersity | Recruiting | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| HRS-5817 Injection Placebo |
| Drug |
HRS-5817 injection placebo administered subcutaneously (SC). |
|
| Maximum concentration (Cmax) |
| 0 to anticipated 253 days. |
| Time to reach maximum concentration (Tmax) | 0 to anticipated 253 days. |
| Half-life (t1/2) | 0 to anticipated 253 days. |
| Apparent clearance (CL/F) | 0 to anticipated 253 days. |
| Proportion of anti-drug antibodies (ADA) positive subjects | 0 to anticipated 253 days. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |