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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03651466

Enrollment

Registered

2018-08-29

Start date

2017-08-31

Completion date

2018-06-28

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

Interventions

DRUGGx-G6

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

DRUGPlacebo

Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
Incidence, nature and severity of Adverse events	Throughout 4 weeks of study	All safety data will be evaluated descriptively

Secondary

Measure	Time frame	Description
Pharmacodynamics(PD) variables	Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing	Oral glucose tolerance test in mol/L
Pharmacokinetics(PK) variables	Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing	GX-G6 concentration in blood

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026