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This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec injection serves as the active control and is administered in an open-label manner.
The study will be conducted across 5 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) and 1 active control cohort of insulin degludec (0.4 U/kg [2.4 nmol/kg]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male subjects.
In Cohort 1 (1 nmol/kg), subjects will be randomized in a 4:1 ratio to receive either UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), subjects will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Subjects in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Cohorts 1-4 will follow a double-blind design, while Cohort 5 will be open-label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UBT38006 | Experimental | s.c, single dose |
|
| Placebo | Placebo Comparator | s.c, single dose |
|
| Active Control | Active Comparator | 0.4U/kg Insulin Degludec Injection,single subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UBT38006 | Drug | Ascending single doses - 4 dose levels |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,.. | Baseline to Day43 |
| Measure | Description | Time Frame |
|---|---|---|
| GIRmax | Baseline to Day43 | |
| Tmax,GIR | Baseline to Day43 | |
| AUCGIR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Huang | Contact | +86 15940441913 | huangyu_0518@tul.com.cn |
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| Drug |
Ascending single doses - 4 dose levels |
|
| Insulin Degludec Injection | Drug | single subcutaneous injection |
|
| Baseline to Day43 |
| Cmax | Baseline to Day43 |
| Tmax | Baseline to Day43 |
| t1/2z | Baseline to Day43 |
| AUC0-t | Baseline to Day43 |
| AUCGIR,0-t | Baseline to Day43 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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