Safety and Tolerability of GX-G6 in Healthy Male Subjects

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.

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Gx-G6; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neu-Ulm, Germany, 89231
    • NUVISAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Experimental: 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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Experimental: 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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Experimental: 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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Experimental: (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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Experimental: (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)	Drug: Gx-G6; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Drug: Placebo; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Study Director: mi-sun byun, Ph. D, Genexine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: GX-G6_HV1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No