NCT03651466

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

July 5, 2018

Last Update Submit

August 27, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Incidence, nature and severity of Adverse events

    All safety data will be evaluated descriptively

    Throughout 4 weeks of study

Secondary Outcomes (2)

  • Pharmacodynamics(PD) variables

    Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing

  • Pharmacokinetics(PK) variables

    Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing

Study Arms (6)

Cohort 1: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

Cohort 2: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

Cohort 3: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

Cohort 4: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

(Optional) Cohort 5: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

(Optional) Cohort 6: GX-G6 + placebo

EXPERIMENTAL

Single administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects)

Drug: Gx-G6Drug: Placebo

Interventions

Gx-G6DRUG

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

(Optional) Cohort 5: GX-G6 + placebo(Optional) Cohort 6: GX-G6 + placeboCohort 1: GX-G6 + placeboCohort 2: GX-G6 + placeboCohort 3: GX-G6 + placeboCohort 4: GX-G6 + placebo
PlaceboDRUG

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

(Optional) Cohort 5: GX-G6 + placebo(Optional) Cohort 6: GX-G6 + placeboCohort 1: GX-G6 + placeboCohort 2: GX-G6 + placeboCohort 3: GX-G6 + placeboCohort 4: GX-G6 + placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male subjects aged between 18-50 years (both inclusive)
  • healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
  • subjects who are able and willing to give written informed consent
  • 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.

You may not qualify if:

  • History of:
  • clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
  • 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;
  • diabetes mellitus and thyroid dysfunction or other endocrine disorders;
  • malignancy;
  • substance abuse or addiction (alcohol, drugs) in the past 3 years.
  • Present Condition:
  • participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
  • participation in this study at a previous dose level;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NUVISAN

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • mi-sun byun, Ph. D

    Genexine, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

August 29, 2018

Study Start

August 31, 2017

Primary Completion

June 6, 2018

Study Completion

June 28, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

DE(1)