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This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.
The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | oral adminstration of SHR1459, dose 1 |
|
| Cohort 2 | Experimental | oral adminstration of SHR1459, dose 2 |
|
| Cohort 3 | Experimental | oral adminstration of SHR1459, dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1459 | Drug | oral adminstration, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single oral doses of SHR1459 determined by adverse events | Frequency and severity of AEs and serious AEs | within 4 days after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhang, MD | Contact | +86-512-67780040 | sdfyy8040@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xu qian, M.D. Ph.D | Recruiting | Shanghai | China |
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