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This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of RAY1225
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAY1225(Part A) | Experimental | Escalating doses of RAY1225 administered subcutaneously (SC) once in healthy participants. |
|
| Placebo (Part A) | Experimental | Placebo administered SC once in healthy participants. |
|
| RAY1225 (Part B) | Experimental | Escalating doses RAY1225 administered SC once weekly for four weeks in healthy participants. |
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| Placebo (Part B) | Experimental | Placebo administered SC once weekly for four weeks in healthy participants. |
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| RAY1225(Part C) | Experimental | Three dose levels of RAY1225 administered SC once weekly for four weeks in participants with Obese. |
|
| Placebo (Part C) | Experimental | Placebo administered SC once weekly for four weeks in participants with Obese. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAY1225 | Drug | Administered SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Baseline through Day 29 (Part A) |
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞) | Baseline through Day 29 (Part A) | |
| To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞) | Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital,South Medical Hospital | Guangzhou | Guangdong | China |
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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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|
| Drug |
Administered SC |
|
| RAY1225 | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
| RAY1225 | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
| To determine the Pharmacodynamics of RAY1225(Change in Body Weight) | Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C) |
| To determine the Pharmacodynamics of RAY1225(Change in Waist circumference) | Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |