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This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A(Part A) | Experimental | Drug1: HRS5685, dose 1; Drug2: Placebo |
|
| Treatment group B(Part A) | Experimental | Drug1: HRS5685, dose 2; Drug2: Placebo |
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| Treatment group C(Part A) | Experimental | Drug1: HRS5685, dose 3; Drug2: Placebo |
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| Treatment group D(Part A) | Experimental | Drug1: HRS5685, dose 4; Drug2: Placebo |
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| Treatment group E(Part A) | Experimental | Drug1: HRS5685, dose 5; Drug2: Placebo |
|
| Treatment group F(Part A) | Experimental | Drug1: HRS5685, dose 6; Drug2: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS5685;Placebo | Drug | Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Incidence and severity of adverse events | Up to Day 63 after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve during a dosing interval (AUCtau), | Pre-dose up to Day 63 after the last dose | |
| Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t) | Pre-dose up to Day 63 after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liping Ma | Contact | 0518-82342973 | liping.ma@hengrui.com | |
| Shujin Cheng | Contact | 0518-82342973 | shujin.cheng@hengrui.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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This is a randomized, double-blinded, placebo-controlled study
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| Treatment group G(Part B) | Experimental | Drug1: HRS5685, dose 3; Drug2: Placebo |
|
| Treatment group H(Part B) | Experimental | Drug1: HRS5685, dose 4; Drug2: Placebo |
|
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf ) | Pre-dose up to Day 63 after the last dose |
| Maximum observed concentration (Cmax) | Pre-dose up to Day 63 after the last dose |
| Time to Maximum observed concentration (Tmax) | Pre-dose up to Day 63 after the last dose |
| Half-life (t1/2), | Pre-dose up to Day 63 after the last dose |
| Apparent clearance (CL/F) | Pre-dose up to Day 63 after the last dose |
| Apparent volume of distribution (Vz/F) | Pre-dose up to Day 63 after the last dose |
| Trough concentration (Ctrough) | Pre-dose up to Day 63 after the last dose |
| Accumulation ratio (Rac), | Pre-dose up to Day 63 after the last dose |
| Renal clearance (CLr) | Pre-dose up to 72 hours post-dose |
| Cumulative amount of drug excreted (Ae) | Pre-dose up to 72 hours post-dose |
| Cumulative percentage of dose recovered (fe) | Pre-dose up to 72 hours post-dose |