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The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS4800 tablets | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS4800 tablets | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Adverse Events (AEs) | 1-21 days | |
| Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities | 1-21 days | |
| Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities | 1-21 days | |
| Proportion of Participants with Vital Sign and Physical Examinations Abnormalities | 1-21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of HRS4800, | 1-6 days | |
| Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800, | 1-6 days | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li Yue | Contact | 86-021-61623632 | li.yue@hengrui.com | |
| Miaoyan Chen | Contact | 86- 021-61623632 | Miaoyan.chen@hengrui.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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HRS4800 tablets single administration in healthy male
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|
| placebo | Drug |
|
|
| 1-6 days |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800 | 1-6 days |
| Apparent Terminal Elimination Half-Life (t1/2) of HRS4800, | 1-6 days |
| Elimination Rate Constant (λz, or kel) of HRS4800, | 1-6 days |
| Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800 | 1-6 days |
| Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu) | 1-6 days |
| Total HRS4800 of Fraction of Dose Excreted in Urine (feu) | 1-6 days |