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This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Drug: HRS-7535 |
|
| Group B | Placebo Comparator | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 | Drug | Drug: HRS-7535 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse Events | Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs; | Day-2 to last follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t | Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t); | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimei Xu | Contact | 0518-82342973 | yimei.xu@hengrui.com | |
| Shujin Cheng | Contact | 0518-82342973 | shujin.cheng@hengrui.com |
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HRS-7535 tablet compared with placebo
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| Drug |
Drug: Placebo |
|
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞);
| pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Cmax | Maximum observed concentration (Cmax); | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Tmax | Time to maximum observed concentration (Tmax); | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - t1/2 | Terminal elimination half-life (t1/2) | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - CL/F | Apparent clearance (CL/F); | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Vz/F | Apparent volume of distribution (Vz/F); | pre-dose to 96 hours post-dose |
| Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss | Area under the plasma concentration-time curve from time zero to tau at steady state (AUC0-τ,ss) | pre-last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss | AUC0-t at steady state (AUC0-t,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss | AUC0-∞ at steady state (AUC0-∞,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss | Tmax at steady state (Tmax,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss | Cmax at steady state (Cmax,ss) | pre- last doseto 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss | Ctrough at steady state (Ctrough,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss | Cavg at steady state (Cavg,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - DF | Degree of fluctuation at steady state (DF) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F | Vz/F at steady state (Vz,ss/F) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - CLss/F | CL/F at steady state (CLss/F) | pre- last dose to 96 hours post- last dose |
| Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss | t1/2 at steady state (t1/2,ss) | pre- last dose to 96 hours post- last dose |
| Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose | pre-dose to 24 hours post-dose |
| Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin | pre-dose to 24 hours post-dose |
| Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide | pre-dose to 24 hours post-dose |
| Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon | pre-dose to 24 hours post-dose |
| Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine | pre-dose up to 96 hours after the last dose |
| PD profile of multiple doses of HRS-7535 - HbA1c | pre-dose up to 96 hours after the last dose |
| PD profile of multiple doses of HRS-7535 - 5-points glucose profile | pre-dose up to 24 hours after the last dose |
| PD profile of multiple doses of HRS-7535 - weight | pre-dose up to 96 hours after the last dose |