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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
NUVISAN
Neu-Ulm, Germany
Incidence, nature and severity of Adverse events
All safety data will be evaluated descriptively
Time frame: Throughout 4 weeks of study
Pharmacodynamics(PD) variables
Oral glucose tolerance test in mol/L
Time frame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Pharmacokinetics(PK) variables
GX-G6 concentration in blood
Time frame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
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