Safety and Tolerability of GX-G6 in Healthy Male Subjects

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A First-in-Human, Single Ascending Dose, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Subcutaneously Administered GX-G6 in Male Healthy Volunteers.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Gx-G6
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male subjects aged between 18-50 years (both inclusive) healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing subjects who are able and willing to give written informed consent male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing. 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: GX-G6 + placebo<br>Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|
| Experimental: Cohort 2: GX-G6 + placebo<br>Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|
| Experimental: Cohort 3: GX-G6 + placebo<br>Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|
| Experimental: Cohort 4: GX-G6 + placebo<br>Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|
| Experimental: (Optional) Cohort 5: GX-G6 + placebo<br>Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|
| Experimental: (Optional) Cohort 6: GX-G6 + placebo<br>Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects) | Drug: Gx-G6<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>Drug: Placebo<br>* Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, nature and severity of Adverse events | All safety data will be evaluated descriptively | Throughout 4 weeks of study | 

Secondary Outcome Measures

| Outcome Measure | 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 | Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing |