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This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-332 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-332 | Experimental | Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet |
|
| Placebo | Placebo Comparator | Single ascending doses of placebo; Multiple ascending doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-332 | Drug | ICP-332 will be administered as tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events (AEs). | Baseline up to 28 days after last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Maximum concentration (Cmax) | Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14. | |
| Change from baseline in blood cells. | measuraments (e.g. blood biochemistry tests, hematology, coagulation tests); outcome measure (e.g. absolute blood cells count) |
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Inclusion Criteria:
Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg.
Age and fertility status
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Wen | Jinan Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | 250013 | China |
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| Other |
Matching placebo will be administered as tablet |
|
| Multiple ascending dose: Baseline to 28 days. |