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The purposes of this study are to:
Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug).
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM-002-1005 61.5 mg or matching placebo | Experimental | Single dose of 61.5 mg HM-002-1005 or matching placebo |
|
| HM-002-1005 123 mg or matching placebo | Experimental | Single dose of 123 mg HM-002-1005 or matching placebo |
|
| HM-002-1005 184.5 or 246 mg, or matching placebo | Experimental | Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo |
|
| HM-002-1005 369 mg or matching placebo | Experimental | Single dose of 369 mg HM-002-1005 or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM-002-1005 | Drug | HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | incidence and severity of adverse events from Day1 to Day 11 | 11 Days |
| Area under the plasma concentration versus time curve (AUC) | area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma | 72 hour |
| maximum observed concentration (Cmax) | Cmax of HM-002-1005 in plasma | 72 hours |
| time of the maximum observed concentration (Tmax) | Tmax of HM-002-1005 in plasma | 72 hours |
| apparent terminal elimination half life (t1/2) | t1/2 of HM-002-1005 in plasma | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| glucose concentration following single oral dose of HM-002-1005 | serum glucose concentration over 24 hours after dosing | 24 hours |
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Inclusion Criteria:
Males or females, of any race, between 18 and 65 years of age, inclusive.
Body mass index between 18.5 and 38.0 kg/m2, inclusive.
Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
Except for findings consistent with T2DM, in good health, determined from medical history, 12 lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the investigator (or designee).
Glycated hemoglobin between 6.5% and 9.5%, inclusive.
Fasting plasma glucose between 126 and 196 mg/dL (7 and 11 mmol/L, respectively), inclusive. Testing may be repeated once, at the discretion of the investigator (or designee).
Other Inclusions
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander N Prezioso, MD | Clinical Pharmacology of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Hialeah | Florida | 33014 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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single oral dose escalation study
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matching placebo control
|
| D004700 | Endocrine System Diseases |