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The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.
This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers.
The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects.
The secondary objectives include:
Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment.
Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS5552 dose 1 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
|
| HMS5552 dose 2 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
|
| HMS5552 dose 3 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
|
| HMS5552 dose 4 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
|
| HMS5552 dose 5 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
|
| HMS5552 dose 6 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements. | up to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2. | Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose. | up to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XueNing LI, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hua Medicine Limited | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000629807 | Dorzagliatin |
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| Placebo | Drug |
|
| Pharmacodynamic variables will include maximum change (%) in fasting plasma glucose level, AUC0-4 of fasting plasma glucose , AUC of percent reduction in fasting plasma glucose from baseline versus time curve, time of minimum glucose level | up to 6 hours post-dose |
| D004700 | Endocrine System Diseases |