Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02750553 | A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers | PHASE1 | COMPLETED | 51 | — | — | Jan 1, 2015 | - | Apr 26, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| Pre-test | EXPERIMENTAL | Three healthy male subjects were randomized in 2:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
| Cohort 1 | EXPERIMENTAL | Eight healthy subjects were randomized in 3:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
| Cohort 2 | EXPERIMENTAL | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 10 mg SHR0534 or matching placebo. |
| Cohort 3 | EXPERIMENTAL | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 25 mg SHR0534 or matching placebo. |
| Cohort 4 | EXPERIMENTAL | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 50 mg SHR0534 or matching placebo. |
| Cohort 5 | EXPERIMENTAL | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 100 mg SHR0534 or matching placebo. |
| Name | Type | Description |
|---|---|---|
| SHR0534 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Must have a BMI between 18 to 24.9 kg/m2, inclusive; * Clinical laboratory tests (i.e.blood chemistries, and urinalysis) must be within the normal reference range or clinically acceptable as determined by the investigator; * Subjects must be free of any clinically significant ...