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To evaluate the safety of SPH7854 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH7854 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH7854 | Drug | SPH7854: Orally, 50-3200mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PK(Pharmacokinetics):Tmax | Time to peak plasma concentration (Tmax) | Approximately 2 years |
| PK(Pharmacokinetics):Cmax | Maximum serum concentration(Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Yu | Contact | 0086-028-85501685 | hxeyyb@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital, Sichuan University | Recruiting | Chengdu | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Drug |
Placebo:Orally; |
|
| Approximately 2 years |
| PK(Pharmacokinetics):AUC | Area under the plasma concentration versus time curve (AUC) | Approximately 2 years |