NCT03651466

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-31
• Primary completion: 2018-06-06
• Completion: 2018-06-28
• First posted: 2018-08-29
• Last updated: 2018-08-29

Locations

1 site across 1 country: Germany