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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 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03651466
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 31, 2017
Completion date June 28, 2018
View Details
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