HealthyPhase 1GX-G3NCT01951027
Phase I Study GX-G3 in Healthy Subjects
A Phase 1 study of Healthy, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2014
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects may be entered in the study only if they meet all of the following criteria:
- Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
- Healthy male volunteers aged 20-45 years;
- Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2;
- Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);
Who cannot join
- Subjects presenting with any of the following will not be entered in to the study:
- Have a history of or current evidence of disease;
- Have percent of white blood cell (WBC) or neutrophil > UNL;
- Have count of platelet < 100,000/mm3;
- Have the longest length of spleen > 16 cm measured by abdomen ultrasonography ;
- Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes)
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- Have clinically significant arrhythmia by EKG/ECG;
- Are positive for HBV, HCV, HIV;
- Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;
- Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;
- Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;
- Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;
- Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;
- Have a history of G-CSF treatment;
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Jung-gu, Daejeon, 301-721
About this study
Official title: A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.
Read the detailed description
MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation.
The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.
- Conditions
- Healthy
- Being tested
- GX-G3 12.5 μg/kg or Placebo, GX-G3 25 μg/kg or Placebo, GX-G3 50 μg/kg or Placebo, GX-G3 100 μg/kg or Placebo
- Keywords
- Safety, Pharmacokinetics, Pharmacodynamics, DLT, Immunogenecity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-G3 12.5 μg/kg or PlaceboDrug
Also called GX-G3(G-CSF-hyFc)
Single SC injection
GX-G3 25 μg/kg or PlaceboDrug
Also called GX-G3(G-CSF-hyFc)
Single SC injection
GX-G3 50 μg/kg or PlaceboDrug
Also called GX-G3(G-CSF-hyFc)
Single SC injection
GX-G3 100 μg/kg or PlaceboDrug
Also called GX-G3(G-CSF-hyFc)
Single SC injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | GX-G3 12.5 μg/kg or Placebo Receives: Drug: GX-G3 12.5 μg/kg or Placebo |
| Cohort 2 | Experimental | GX-G3 25 μg/kg or Placebo Receives: Drug: GX-G3 25 μg/kg or Placebo |
| Cohort 3 | Experimental | GX-G3 50 μg/kg or Placebo Receives: Drug: GX-G3 50 μg/kg or Placebo |
| Cohort 4 | Experimental | GX-G3 100 μg/kg or Placebo Receives: Drug: GX-G3 100 μg/kg or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT incidence and frequency after GX-G3 single S.C. injection
[DLT criteria: CTCAE V4.03]
- Hematologic type: grade 3 Hematologic N.O.S, grade 3 or 4 Leukocytosis
- Non-Hematologic: grade 3 N.O.S
- N.O.S: not otherwise specified
- Leukocytosis: continued more than 5 days, grade 3(>100,000 cells/mm3), or grade 4(clinical manifestations of leucostasis; urgent intervention indicated)
Measured: 6 weeks
Secondary outcomes (3)
Adverse events incidence and frequency at each dose group after GX-G3 single injection
Measured: 6 weeks
Pharmacokinetics parameters after GX-G3 single injection
AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
Measured: 3 weeks
Pharmacodynamics parameters after GX-G3 single injection
Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-In Yang, Ph.D, Study director, Genexine, Inc, Clinical development DepartmentJae Woo Kim, M.D., Principal investigator, CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951027
- Sponsor's protocol ID
- GX-G3_HV_1
- Acronym
- GX-G3
- Status last verified
- Jan 2015
- First submitted
- 17 Sep 2013
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01951027
- Acronym / sponsor ID
- GX-G3 / GX-G3_HV_1
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics, Pharmacodynamics, DLT, Immunogenecity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Sep 2013 (estimated)
- 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.
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.
Detailed description
MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation.
The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GX-G3 12.5 μg/kg or PlaceboGX-G3 12.5 μg/kg or Placebo |
| Cohort 2 | Experimental | Drug: GX-G3 25 μg/kg or PlaceboGX-G3 25 μg/kg or Placebo |
| Cohort 3 | Experimental | Drug: GX-G3 50 μg/kg or PlaceboGX-G3 50 μg/kg or Placebo |
| Cohort 4 | Experimental | Drug: GX-G3 100 μg/kg or PlaceboGX-G3 100 μg/kg or Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
- Healthy male volunteers aged 20-45 years;
- Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2;
- Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);
Key exclusion criteria (14 listed)
- Have a history of or current evidence of disease;
- Have percent of white blood cell (WBC) or neutrophil > UNL;
- Have count of platelet < 100,000/mm3;
- Have the longest length of spleen > 16 cm measured by abdomen ultrasonography ;
- Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes)
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-G3 12.5 μg/kg or PlaceboAlso: GX-G3(G-CSF-hyFc)Single SC injection | Drug | Cohort 1 |
| GX-G3 25 μg/kg or PlaceboAlso: GX-G3(G-CSF-hyFc)Single SC injection | Drug | Cohort 2 |
| GX-G3 50 μg/kg or PlaceboAlso: GX-G3(G-CSF-hyFc)Single SC injection | Drug | Cohort 3 |
| GX-G3 100 μg/kg or PlaceboAlso: GX-G3(G-CSF-hyFc)Single SC injection | Drug | Cohort 4 |
Primary outcome
DLT incidence and frequency after GX-G3 single S.C. injection
Time frame: 6 weeks
[DLT criteria: CTCAE V4.03] 1. Hematologic type: grade 3 Hematologic N.O.S, grade 3 or 4 Leukocytosis 2. Non-Hematologic: grade 3 N.O.S * N.O.S: not otherwise specified * Leukocytosis: continued more than 5 days, grade 3(>100,000 cells/mm3), or grade 4(clinical manifestations of leucostasis; urgent intervention indicated)
3 secondary outcomes
Adverse events incidence and frequency at each dose group after GX-G3 single injection
Time frame: 6 weeks
Pharmacokinetics parameters after GX-G3 single injection
Time frame: 3 weeks
Pharmacodynamics parameters after GX-G3 single injection
Time frame: 3 weeks
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 Jan 2015.
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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.
Sang-In Yang, Ph.D study director
Genexine, Inc, Clinical development Department
Jae Woo Kim, M.D. principal investigator
CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
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 of Healthy, run by Genexine, Inc. at 1 site in South Korea.
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 5 inclusion and 14 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 Jan 2015. 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 South Korea. 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?
DLT incidence and frequency after GX-G3 single S.C. injection (time frame: 6 weeks). 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 Jan 2015.