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This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo tablet | Placebo Comparator |
| |
| IBI353 (Orismilast) dose 2 | Experimental |
| |
| IBI353 (Orismilast) dose 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI353 (Orismilast) | Drug | dose 1 or dose 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Maximal Concentration (Cmax) of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Volume of Distribution (Vd/F) of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Half life time of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Clearance (CL/F) of IBI353 and its related metabolites. | Baseline through Day 21 | |
| Accumulation Ratio of IBI353 and its related metabolites. | Baseline through Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), gastrointestinal AEs, and changes of vital signs, lab examinations, physical examinations, ECGs in healthy subjects after drug administration. | Baseline through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| placebo | Drug | placebo |
|