Safety and Tolerability of GX-G6 in Healthy Male Subjects

NCT ID: NCT03651466

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2018-06-28

Brief Summary

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

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Cohort 2: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Cohort 3: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Cohort 4: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

(Optional) Cohort 5: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

(Optional) Cohort 6: GX-G6 + placebo

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

Group Type: EXPERIMENTAL

Gx-G6

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Placebo

Intervention Type: DRUG

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Interventions

Gx-G6

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Intervention Type: DRUG

Placebo

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mi-sun byun, Ph. D

Role: STUDY_DIRECTOR

Genexine, Inc.

Locations

NUVISAN

Neu-Ulm, , Germany

Countries

Germany

Other Identifiers

GX-G6_HV1

Identifier Type: -

Identifier Source: org_study_id