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This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HW201877 capsules | Experimental | Single or multiple oral doses of HW201877 capsules, and food effect of HW201877 capsules |
|
| Placebo | Placebo Comparator | Single or multiple oral doses of placebo, and food effect of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HW201877 capsules | Drug | Dose 1 to Dose 7 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers | Day 1 to Day 5 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | 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 |
Dose 1 to Dose 7 |
|