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This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6
A screening examination will be performed within 28 days prior to dosing. Eligible subjects will return to the study center in the morning of Day -1 and will remain in-patient until discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of Day 5) if there are no safety issues. The s.c. injection will be administered in the morning of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take place on Day 15 and a final visit on Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects) |
|
| Cohort 2: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects) |
|
| Cohort 3: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects) |
|
| Cohort 4: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects) |
|
| (Optional) Cohort 5: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gx-G6 | Drug | Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature and severity of Adverse events | All safety data will be evaluated descriptively | Throughout 4 weeks of study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics(PD) variables | Oral glucose tolerance test in mol/L | Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing |
| Pharmacokinetics(PK) variables | GX-G6 concentration in blood |
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Inclusion Criteria:
Exclusion Criteria:
History of:
clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;
diabetes mellitus and thyroid dysfunction or other endocrine disorders;
malignancy;
substance abuse or addiction (alcohol, drugs) in the past 3 years.
Present Condition:
participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
participation in this study at a previous dose level;
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| Name | Affiliation | Role |
|---|---|---|
| mi-sun byun, Ph. D | Genexine, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUVISAN | Neu-Ulm | 89231 | Germany |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| (Optional) Cohort 6: GX-G6 + placebo | Experimental | Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects) |
|
| Placebo | Drug | Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion. |
|
| Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing |