Safety and Tolerability of GX-G6 in Healthy Male Subjects

Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651466
• Other study ID #: GX-G6_HV1
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: August 2018
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 28, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Gx-G6
Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
• Placebo
Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Locations

Country	Name	City	State
Germany	NUVISAN	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature and severity of Adverse events	All safety data will be evaluated descriptively	Throughout 4 weeks of study
Secondary	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
Secondary	Pharmacokinetics(PK) variables	GX-G6 concentration in blood	Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing