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The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HR071603,nasal spray,dose escalation. |
|
| Treatment group B | Placebo Comparator | Placebo, nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR071603 | Drug | HR071603 monotherapy ,nasal spray |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (Safety and Tolerability) | Pre-dose to Day8 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter-Area under drug-time curve (AUC) | Pre-dose to Day2 | |
| Assessment of PK parameter-peak time (Tmax) | Pre-dose to Day2 | |
| Assessment of PK parameter-peak concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing AnDing hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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HR071603 monotherapy
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| placebo | Drug | placebo,nasal spray |
|
| Pre-dose to Day2 |
| Assessment of PK parameter-half-life (t1/2) | Pre-dose to Day2 |
| Assessment of PK parameter-apparent clearance rate (CL/F) | Pre-dose to Day2 |
| Assessment of PK parameter-apparent distribution volume (Vz/F) | Pre-dose to Day2 |