Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1 open-label study.
This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: SHR8735 cohort 1 | Experimental | The subjects will receive a multiple dose of SHR8735 (low dose). |
|
| Experimental: SHR8735 cohort 2 | Experimental | The subjects will receive a single dose of SHR8735 (medium dose). |
|
| Experimental: SHR8735 cohort 3 | Experimental | The subjects will receive a single dose of SHR8735 (high dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8735 | Drug | SHR8735 is an thrombopoietin receptor agonist to promote platelet production. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR8735 administration | Start of Treatment to end of study (approximately 15 days) |
| Pharmacokinetics-AUC0-inf |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Sun, Dr | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical research | Perth | Western Australia | 6009 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Area under the concentration-time curve from time 0 to infinity after SHR8735 administration
| Start of Treatment to end of study (approximately 15 days) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR8735 | Up to 15 days |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR8735 | Up to 15 days |
| Pharmacokinetics-CL/F | Apparent clearance of SHR8735 | Up to 15 days |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR8735 | Up to 15 days |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR8735 | Up to 15 days |
| Change from baseline to end of treatment for platelet count | Up to 28 days |