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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-3095 Group | Experimental |
| |
| HRS-3095 Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3095 Tablet | Drug | Oral HRS-3095 tablet. |
| |
| HRS-3095 Placebo Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 21 days. | |
| Incidence of serious adverse events (SAEs) | Up to 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Up to 17 days. | |
| Time of maximum concentration (Tmax) | Up to 17 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Frist Clinical Medicial College of Qingdao University | Qingdao | Shandong | 266555 | China |
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| Drug |
Oral HRS-3095 placebo tablet. |
|
| Up to 17 days. |
| Area under the concentration-time curve from time zero to infinity (AUC0-inf) | Up to 17 days. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau) | Up to 17 days. |
| Elimination half-life (t1/2) | Up to 17 days. |
| Apparent clearance (CL/F) | Up to 17 days. |
| Apparent volume of distribution (Vz/F) | Up to 17 days. |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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