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The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: HRS-5817 dose level 1 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 1) |
|
| Experimental: HRS-5817 dose level 2 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 2) |
|
| HRS-5817 dose level 3 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 3) |
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| HRS-5817 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5817 | Drug | Single dose of HRS-5817/placebo given subcutaneously (dose level 1 ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Number of participants with Adverse events and Serious adverse events | Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax | Maximum observed plasma concentration (Cmax) | Day 253 |
| Pharmacokinetics - AUC₀-t | Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf) |
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Inclusion Criteria:
Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Exclusion Criteria:
1. History or evidence of clinically significant disorders 2. Individuals with a weight change of more than 5kg within 3 months prior to the screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear | Perth | Western Australia | 6027 | Australia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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HRS-5817 subcutaneous administration
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| HRS-5817 | Drug | Single dose of HRS-5817/placebo given subcutaneously (dose level 2 ) |
|
| HRS-5817 | Drug | Single dose of HRS-5817/placebo given subcutaneously (dose level 3 ) |
|
| HRS-5817 | Drug | Single dose of HRS-5817/placebo given subcutaneously (dose level 4) |
|
| Day 253 |
| Pharmacokinetics - Tmax | Time to reach maximum observed plasma concentration (Tmax) | Day 253 |
| Pharmacokinetics - t½ | Terminal elimination half-life (t½) | Day 253 |
| Immunogenicity - Anti-Drug Antibody (ADA) | Incidence and onset time of anti-drug antibody (ADA) | Day 253 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |