Safety and Tolerability of GX-G6 in Healthy Male Subjects

Genexine

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Gx-G6

Study type: Interventional

Funder types: Industry

Identifiers

NCT03651466

GX-G6_HV1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. male subjects aged between 18-50 years (both inclusive)
2. healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
3. subjects who are able and willing to give written informed consent
4. 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:

1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;

2. 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;

3. diabetes mellitus and thyroid dysfunction or other endocrine disorders;

4. malignancy;

5. substance abuse or addiction (alcohol, drugs) in the past 3 years.

   Present Condition:

6. participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;

7. participation in this study at a previous dose level;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Cohort 1: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6

Cohort 2: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6

Cohort 3: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6

Cohort 4: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6

(Optional) Cohort 5: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6

(Optional) Cohort 6: GX-G6 + placebo

Experimental group

Description:

Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects)

Treatment:

Drug: Placebo

Drug: Gx-G6