Clinical trial NCT03651466: Safety and Tolerability of GX-G6 in Healthy Male Subjects
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Incidence, nature and severity of Adverse events
timeFrame: Throughout 4 weeks of study
Secondary outcomes:
measure: Pharmacodynamics(PD) variables
timeFrame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
measure: Pharmacokinetics(PK) variables
timeFrame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: NUVISAN
Study officials:
affiliation: Genexine, Inc.
name: mi-sun byun, Ph. D
role: STUDY_DIRECTOR
References: