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This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSS0343 Tablets Group | Experimental |
| |
| RSS0343 Tablets Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0343 Tablets | Drug | RSS0343 tablets, oral. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of any adverse events (AEs). | Safety and tolerability. | Evaluation was performed up to Day 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Xu | Contact | +86-0518-81220121 | ye.xu.yx1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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| RSS0343 Tablets Placebo |
| Drug |
RSS0343 tablets placebo, oral. |
|
Pharmacokinetics (PK) indicator.
| Evaluation was performed up to Day 28. |
| Time to Cmax (Tmax). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Time to Cmax,ss (Tmax,ss). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Area under the concentration-time curve during a dosing interval (AUC0-tau). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Area under the concentration-time curve from 0 to the last measurable time point after RSS0343 administration (AUC0-t). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Terminal elimination half-life of RSS0343 (t1/2). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Cumulative amount of drug excreted in urine (Ae,urine). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Cumulative percentage of dose recovered in urine (Fe,urine). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Renal clearance of RSS0343 (CLr). | Pharmacokinetics (PK) indicator. | Evaluation was performed up to Day 28. |
| Changes in the QTc interval corrected by the Fridericia method relative to baseline (ΔQTcF) (where applicable). | To evaluate the effects of RSS0343 on the QT/QTc interval in healthy subjects. | Evaluation was performed up to Day 28. |