Diabetes MellitusPhase 1NCT03651466
Safety and Tolerability of GX-G6 in Healthy Male Subjects
A Phase 1 study testing Gx-G6 in people with Diabetes Mellitus, run by Genexine, Inc. at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Gx-G6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2017to 28 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Gx-G6, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gx-G6Drug
Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
PlaceboDrug
Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Gx-G6; Drug: 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) Receives: Drug: Gx-G6; Drug: 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) Receives: Drug: Gx-G6; Drug: 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) Receives: Drug: Gx-G6; Drug: 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) Receives: Drug: Gx-G6; Drug: 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) Receives: Drug: Gx-G6; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of Adverse events
All safety data will be evaluated descriptively
Measured: Throughout 4 weeks of study
Secondary outcomes (2)
Pharmacodynamics(PD) variables
Oral glucose tolerance test in mol/L
Measured: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Pharmacokinetics(PK) variables
GX-G6 concentration in blood
Measured: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start31 Aug 2017
- Primary completion6 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- mi-sun byun, Ph. D, Study director, Genexine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651466
- Sponsor's protocol ID
- GX-G6_HV1
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03651466
- Acronym / sponsor ID
- GX-G6_HV1
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level I) GX-G6 (6 subjects) and pre-determined dose (Level I) placebo (2 subjects) |
| Cohort 2: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level II) GX-G6 (6 subjects) and pre-determined dose (Level II) placebo (2 subjects) |
| Cohort 3: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level III) GX-G6 (6 subjects) and pre-determined dose (Level III) placebo (2 subjects) |
| Cohort 4: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level IV) GX-G6 (6 subjects) and pre-determined dose (Level IV) placebo (2 subjects) |
| (Optional) Cohort 5: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level V) GX-G6 (6 subjects) and pre-determined dose (Level V) placebo (2 subjects) |
| (Optional) Cohort 6: GX-G6 + placebo | Experimental | Drug: Gx-G6, Drug: PlaceboSingle administration of pre-determined dose (Level VI) GX-G6 (6 subjects) and pre-determined dose (Level VI) placebo (2 subjects) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gx-G6Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion. | Drug | (Optional) Cohort 5: GX-G6 + placebo, (Optional) Cohort 6: GX-G6 + placebo, Cohort 1: GX-G6 + placebo, Cohort 2: GX-G6 + placebo, Cohort 3: GX-G6 + placebo, Cohort 4: GX-G6 + placebo |
| PlaceboEach subject will receive a single dose of either GX-G6 or placebo in randomized fashion. | Drug | (Optional) Cohort 5: GX-G6 + placebo, (Optional) Cohort 6: GX-G6 + placebo, Cohort 1: GX-G6 + placebo, Cohort 2: GX-G6 + placebo, Cohort 3: GX-G6 + placebo, Cohort 4: GX-G6 + placebo |
Primary outcome
Incidence, nature and severity of Adverse events
Time frame: Throughout 4 weeks of study
All safety data will be evaluated descriptively
2 secondary outcomes
Pharmacodynamics(PD) variables
Time frame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Pharmacokinetics(PK) variables
Time frame: Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mi-sun byun, Ph. D study director
Genexine, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gx-G6 in people with Diabetes Mellitus, run by Genexine, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature and severity of Adverse events (time frame: Throughout 4 weeks of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.