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This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2906 Injection Group | Experimental |
| |
| SHR-2906 Injection Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2906 Injection | Drug | SHR-2906 injection, in different doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs). | Part1: 57 days; Part2: 113 days. | |
| Incidence of serious adverse events (SAEs). | Part1: 57 days; Part2: 113 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax). | Part1: 57 days; Part2: 113 days. | |
| Time of maximum concentration (Tmax). | Part1: 57 days; Part2: 113 days. | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi Ye | Contact | +86-0518-81220121 | zi.ye@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | 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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| SHR-2906 Injection Placebo |
| Drug |
SHR-2906 injection placebo. |
|
| Part1: 57 days; Part2: 113 days. |
| Area under the concentration-time curve from time zero to infinity (AUC0-inf). | Part1: 57 days; Part2: 113 days. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau). | Part1: 57 days; Part2: 113 days. |
| Elimination half-life (t1/2). | Part1: 57 days; Part2: 113 days. |
| Apparent clearance (CL/F). | Part1: 57 days; Part2: 113 days. |
| Apparent volume of distribution (Vz/F). | Part1: 57 days; Part2: 113 days. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |