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This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.
The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR419 capsules | Experimental | Ascending single and multiple doses of SR419 orally |
|
| Placebo | Placebo Comparator | Ascending single and multiple doses of SR419 placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR419 capsules | Drug | Ascending single and multiple doses of SR419 orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak plasma concentration | Up to Day 7 |
| Tmax | Time of peak plasma concentration | Up to Day 7 |
| AUC | Area under the plasma concentration-time curve | Up to Day 7 |
| CL/F | Apparent oral clearance | Up to Day 7 |
| t1/2 | Terminal half-life | Up to Day 7 |
| Rac | Accumulation ratio | Up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR419 capsules | AE: Adverse Event | Up to Day12(+7 days) for the safety follow up since Day1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Yu | Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU) | Shanghai | China |
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| Placebo |
| Drug |
Ascending single and multiple doses of placebo orally |
|